HealthyPhase 1NCT05948774
A SAD/MAD Study to Evaluate the Safety, Tolerability, PK of MT200605 in Healthy Subjects
A Phase 1 study testing MT200605 for Injection in people with Healthy, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT200605 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 11 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18.0 and ≤ 28.0 kg/m^2
- Healthy as defined by:
- The absence of clinically significant illness and major surgery within 4 weeks prior to study drug administration.
- The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Participants have no fertility plan, no sperm or egg donation plan in the next 6 months and voluntarily use effective contraception; Female subjects with negative serum pregnancy test results.
- Can understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.
Who cannot join
- -
- Participants will be excluded from the study if any of the following applies:
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening, or active infections.
- Positive pregnancy test or lactating female subject.
- Positive results of urine drug screen and breath alcohol test.
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- History of significant allergic reactions (e.g., Immediate hypersensitivity, hypersensitivity, angioedema) to any drug that the Investigator judges to be clinically significant.
- Clinically significant ECG abnormalities (QTcF ≥ 450 ms) or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, HR less than 50 or over 100 bpm) at screening.
- History of drug abuse within 1 year prior to screening or using of the recreational drugs (such as marijuana, cocaine, phencyclidine [PCP], opioid derivatives (including Morphine, buprenorphine, methadone) or amphetamine derivatives within 3 months prior to screening.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 355 mL of 5% beer, or 150 mL of 12% wine, or 45 mL of 40% distilled alcohol).
- Donation or loss of more than 500 mL blood within 2 months prior to study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months prior to screening, or plans to donate blood during the study or within 3 months after the study.
- Estimated glomerular filtration rate (eGFR) <60 mL/min at screening (estimated with the MDRD equation).
- Participants daily smoking of cigarettes amounts > 5 prior to the 3 months of screening, or get used to usage of nicotine-containing products, or participants who is not accept forbidden of any cigarettes products.
- Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
- Depot injection or implant within 3 months prior to the first dosing.
- Any drug or substances known to be strong inhibitors or strong inducers of CYP3A4/5, transporters of P-gp (e.g. rifampin, St, John´s Wort) within 30 days prior to the first dosing
- Usage of the prescription medications within 14 days prior to the first dosing.
- Usage of the Over-the-counter (OTC) medications (other than ≤2 g/day paracetamol [acetaminophen] or ≤ 800 mg/day ibuprofen) and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing.
- Participants involved in the clinical trials of study drugs, marketed drug, medical devices within 90 days prior to the first dosing, or concomitant participation in an investigational study without drug or medical device administration.
- Poor compliance or unable to comply with the relevant provisions of the research protocol, and any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
About this study
Official title: A Randomized, Double-blind, Placebo Control, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects.
The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects.
The main questions it aims to answer are:
Read more
- The safety and tolerability of MT200605 injection in health subjects
- The Pharmacokinetic characteristic of MT200605 injction in health subjects
The study aims to recruit 60 health subjects and participants will be randomly allocate to two stages (SAD and MAD) with 36 subjects in SAD and 24 subjects in MAD stages.
The placebo will be used in this study, and the researchers will compare the placebo and test article to see if the MT200605 will be safe or well tolerated.
Read the detailed description
Shaanxi Micot Technology Co. Ltd. is developing MT200605, a novel investigational synthetic small molecule tyrosine kinase B (TrkB) receptor agonist to mimic brain-derived neurotrophic factor (BDNF). It can directly bind to TrkB receptor to exert strong neuroprotective and nutritional effects and used for the indication of Treatment of brain tissue damage after cerebral ischemia-reperfusion and nerve repair after ischemic stroke.
The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects. The study was divided into two stages including 5 groups in SAD stage and 3 groups in MAD stage. 4 subjects were in the first corhort (C1) of SAD stage while the rest of the corhorts were 8 cases. The MT200605 and Placebo will be administrated by Intravenous injection.The dose level in SAD will be 0.15 (C1), 0.3(C2), 0.6(C3), 0.9(C4), and 1.2(C5) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD corhort. The dose level in MAD will be 0.3(C6), 0.6(C7), and 1.2(C8) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD and MAD corhort.
- Conditions
- Healthy
- Being tested
- MT200605 for Injection, MT200605 Placebo
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT200605 for InjectionDrug
Also called MT200605
Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.
MT200605 PlaceboDrug
Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 Placebo will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 Placebo for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.
| Study group | Role | What they receive |
|---|---|---|
| MT200605 for injection | Experimental | The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects. Receives: Drug: MT200605 for Injection |
| MT200605 Placebo | Placebo comparator | The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 Placebo in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects. Receives: Drug: MT200605 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events（AEs)
For SAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Adverse Events（AEs)
For MAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Vital signs (SAD)
Vital signs measurements including blood pressure [BP] in mmHG.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Vital signs (MAD)
Vital signs measurements including blood pressure [BP] in mmHG.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Vital signs (SAD)
Vital signs measurements including pulse rate [PR] in beats/minute.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs (MAD)
Vital signs measurements including pulse rate [PR] in beats/minute.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs (SAD)
Vital signs measurements including respiratory rate [RR] in breaths/minute.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs (MAD)
Vital signs measurements including respiratory rate [RR] in breaths/minute.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs (SAD)
Vital signs measurements including axillaty temperature [AT] in Celsius (°C).
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs (MAD)
Vital signs measurements including axillaty temperature [AT] in Celsius (°C).
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (SAD)
The ECG PR Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (SAD)
The ECG QRS Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (SAD)
The ECG RR Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (SAD)
The ECG QT Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (SAD)
The ECG QTc Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (MAD)
The ECG PR Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (MAD)
The ECG QRS Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (MAD)
The ECG RR Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (MAD)
The ECG QT Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
12-lead electrocardiogram (ECG) recordings (MAD)
The ECG QTc Interval will be used to evaluate and monitor the participants.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Head (SAD)
A thorough physical examination will be performed at SAD stage, including head examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Eyes (SAD)
A thorough physical examination will be performed at SAD stage, including eyes examination，the descriptive name of scale （inspection） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Ears (SAD)
A thorough physical examination will be performed at SAD stage, including ears examination，the descriptive name of scale （auscultation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Nose (SAD)
A thorough physical examination will be performed at SAD stage, including nose examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-throat (SAD)
A thorough physical examination will be performed at SAD stage, including throat examination，the descriptive name of scale （inspection） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-neck (SAD)
A thorough physical examination will be performed at SAD stage, including neck examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-lung (SAD)
A thorough physical examination will be performed at SAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Abdomen (SAD)
A thorough physical examination will be performed at SAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-skin (SAD)
A thorough physical examination will be performed at SAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Musculoskeletal (SAD)
A thorough physical examination will be performed at SAD stage, including musculoskeletal examination，the descriptive name of scale（inspection，palpation，percussion） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Cardiovascular (SAD)
A thorough physical examination will be performed at SAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-neurological (SAD)
A thorough physical examination will be performed at SAD stage, including neurological examination，the descriptive name of scale（palpation, percussion）will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-lung (MAD)
A simple physical examination will be performed at MAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Abdomen (MAD)
A simple physical examination will be performed at MAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-skin (MAD)
A simple physical examination will be performed at MAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Physical examinations-Cardiovascular (MAD)
A simple physical examination will be performed at MAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (SAD)
The hematology testing will be performed, the MCH will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (SAD)
The hematology testing will be performed,the Hematocrit will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (SAD)
The hematology testing will be performed,the Hemoglobin will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-biochemistry (SAD)
The biochemistry testing will be performed, the eGFR will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-biochemistry (SAD)
The biochemistry testing will be performed, the serum creatinine will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Urinalysis (SAD)
The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (SAD)
The Urinalysis will be performed, the PT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (SAD)
The Urinalysis will be performed, the aPTT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (SAD)
The Urinalysis will be performed, the INR will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Cardiac Enzymes (SAD)
The Urinalysis will be performed, the TnT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Cardiac Enzymes (SAD)
The Urinalysis will be performed, the TnI will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (MAD)
The hematology testing will be performed, the MCH will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (MAD)
The hematology testing will be performed, the Hematocrit will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-hematology (MAD)
The hematology testing will be performed, the Hemoglobin will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-biochemistry (MAD)
The biochemistry testing will be performed, the eGFR will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-biochemistry (MAD)
The biochemistry testing will be performed, the serum creatinine will be evaluated
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Urinalysis (MAD)
The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (MAD)
The Urinalysis will be performed, the PT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (MAD)
The Urinalysis will be performed, the aPTT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Coagulation (MAD)
The Urinalysis will be performed, the INR will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Cardiac Enzymes (MAD)
The Urinalysis will be performed, the TnT will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Clinical laboratory test-Cardiac Enzymes (MAD)
The Urinalysis will be performed, the TnI will be evaluated.
Measured: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Secondary outcomes (30)
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Area under the plasma concentration versus time curve (AUC)0-t will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The AUC0-inf will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Peak Plasma Concentration (Cmax) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Time to peak drug concentration (Tmax) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Half-life (T½) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Plasma clearance (CL) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The volume of distribution (Vd) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Lambda-z (λz) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Mean Residence Time (MRT) will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The AUC_%Extrap will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Cmax,ss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Tmax,ss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The AUC0-t will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The AUC0-τ will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Cmin,ss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Cav,ss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Ctrough will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The CLss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Vdss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The t1/2,ss will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Rac_AUC0-τ will be calculated.
Measured: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Rac_Cmax will be calculated.
Measured: Up to 2 Days.
Urine PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Ae0-t will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Rmax will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The TRmax will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The CLR will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Ae0-t,ss will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The Rmax,ss will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The TRmax,ss will be calculated.
CLR,ss. (The Urine of 4th Corhort in SAD will be collected and tested for Urine PK).
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
To characterize the pharmacokinetics (PK) of MT200605 for injection in healthy adult subjects. The CLR,ss will be calculated.
Measured: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start11 Jul 2023
- Primary completion22 Jan 2024
- Study completion11 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RuiHua Dong, PhD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948774
- Sponsor's protocol ID
- MT200605-I-C01
- Status last verified
- Nov 2024
- First submitted
- 7 Jun 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Control, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05948774
- Acronym / sponsor ID
- MT200605-I-C01
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 11 Feb 2024 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects.
The main questions it aims to answer are:
- The safety and tolerability of MT200605 injection in health subjects
- The Pharmacokinetic characteristic of MT200605 injction in health subjects
The study aims to recruit 60 health subjects and participants will be randomly allocate to two stages (SAD and MAD) with 36 subjects in SAD and 24 subjects in MAD stages.
The placebo will be used in this study, and the researchers will compare the placebo and test article to see if the MT200605 will be safe or well tolerated.
Detailed description
Shaanxi Micot Technology Co. Ltd. is developing MT200605, a novel investigational synthetic small molecule tyrosine kinase B (TrkB) receptor agonist to mimic brain-derived neurotrophic factor (BDNF). It can directly bind to TrkB receptor to exert strong neuroprotective and nutritional effects and used for the indication of Treatment of brain tissue damage after cerebral ischemia-reperfusion and nerve repair after ischemic stroke.
The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects. The study was divided into two stages including 5 groups in SAD stage and 3 groups in MAD stage. 4 subjects were in the first corhort (C1) of SAD stage while the rest of the corhorts were 8 cases. The MT200605 and Placebo will be administrated by Intravenous injection.The dose level in SAD will be 0.15 (C1), 0.3(C2), 0.6(C3), 0.9(C4), and 1.2(C5) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD corhort. The dose level in MAD will be 0.3(C6), 0.6(C7), and 1.2(C8) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD and MAD corhort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT200605 for injection | Experimental | Drug: MT200605 for InjectionThe Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects. |
| MT200605 Placebo | Placebo comparator | Drug: MT200605 PlaceboThe Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 Placebo in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18.0 and ≤ 28.0 kg/m^2
- Healthy as defined by:
- Participants have no fertility plan, no sperm or egg donation plan in the next 6 months and voluntarily use effective contraception; Female subjects with negative serum pregnancy test results.
- Can understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.
Key exclusion criteria (20 listed)
- -
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening, or active infections.
- Positive pregnancy test or lactating female subject.
- Positive results of urine drug screen and breath alcohol test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT200605 for InjectionAlso: MT200605Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h. | Drug | MT200605 for injection |
| MT200605 PlaceboTwo stages (SAD, MAD) were designed in this study. For SAD, the MT200605 Placebo will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 Placebo for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h. | Drug | MT200605 Placebo |
Primary outcome
Adverse Events（AEs)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
For SAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.
Adverse Events（AEs)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
For MAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.
Vital signs (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Vital signs measurements including blood pressure [BP] in mmHG.
Vital signs (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.
Vital signs measurements including blood pressure [BP] in mmHG.
Vital signs (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including pulse rate [PR] in beats/minute.
Vital signs (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including pulse rate [PR] in beats/minute.
Vital signs (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including respiratory rate [RR] in breaths/minute.
Vital signs (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including respiratory rate [RR] in breaths/minute.
Vital signs (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including axillaty temperature [AT] in Celsius (°C).
Vital signs (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
Vital signs measurements including axillaty temperature [AT] in Celsius (°C).
12-lead electrocardiogram (ECG) recordings (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG PR Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QRS Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG RR Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QT Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QTc Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG PR Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QRS Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG RR Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QT Interval will be used to evaluate and monitor the participants.
12-lead electrocardiogram (ECG) recordings (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The ECG QTc Interval will be used to evaluate and monitor the participants.
Physical examinations-Head (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including head examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Physical examinations-Eyes (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including eyes examination，the descriptive name of scale （inspection） will be used to report this outcome measure.
Physical examinations-Ears (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including ears examination，the descriptive name of scale （auscultation） will be used to report this outcome measure.
Physical examinations-Nose (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including nose examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Physical examinations-throat (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including throat examination，the descriptive name of scale （inspection） will be used to report this outcome measure.
Physical examinations-neck (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including neck examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Physical examinations-lung (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.
Physical examinations-Abdomen (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.
Physical examinations-skin (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Physical examinations-Musculoskeletal (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including musculoskeletal examination，the descriptive name of scale（inspection，palpation，percussion） will be used to report this outcome measure.
Physical examinations-Cardiovascular (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.
Physical examinations-neurological (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A thorough physical examination will be performed at SAD stage, including neurological examination，the descriptive name of scale（palpation, percussion）will be used to report this outcome measure.
Physical examinations-lung (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A simple physical examination will be performed at MAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.
Physical examinations-Abdomen (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A simple physical examination will be performed at MAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.
Physical examinations-skin (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A simple physical examination will be performed at MAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.
Physical examinations-Cardiovascular (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
A simple physical examination will be performed at MAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.
Clinical laboratory test-hematology (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed, the MCH will be evaluated
Clinical laboratory test-hematology (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed,the Hematocrit will be evaluated
Clinical laboratory test-hematology (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed,the Hemoglobin will be evaluated
Clinical laboratory test-biochemistry (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The biochemistry testing will be performed, the eGFR will be evaluated
Clinical laboratory test-biochemistry (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The biochemistry testing will be performed, the serum creatinine will be evaluated
Clinical laboratory test-Urinalysis (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.
Clinical laboratory test-Coagulation (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the PT will be evaluated.
Clinical laboratory test-Coagulation (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the aPTT will be evaluated.
Clinical laboratory test-Coagulation (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the INR will be evaluated.
Clinical laboratory test-Cardiac Enzymes (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the TnT will be evaluated.
Clinical laboratory test-Cardiac Enzymes (SAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the TnI will be evaluated.
Clinical laboratory test-hematology (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed, the MCH will be evaluated
Clinical laboratory test-hematology (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed, the Hematocrit will be evaluated
Clinical laboratory test-hematology (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The hematology testing will be performed, the Hemoglobin will be evaluated
Clinical laboratory test-biochemistry (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The biochemistry testing will be performed, the eGFR will be evaluated
Clinical laboratory test-biochemistry (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The biochemistry testing will be performed, the serum creatinine will be evaluated
Clinical laboratory test-Urinalysis (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.
Clinical laboratory test-Coagulation (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the PT will be evaluated.
Clinical laboratory test-Coagulation (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the aPTT will be evaluated.
Clinical laboratory test-Coagulation (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the INR will be evaluated.
Clinical laboratory test-Cardiac Enzymes (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the TnT will be evaluated.
Clinical laboratory test-Cardiac Enzymes (MAD)
Time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks
The Urinalysis will be performed, the TnI will be evaluated.
30 secondary outcomes
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Plasma PK of free MT200605 and total MT200605 (MAD)
Time frame: Up to 2 Days.
Urine PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Urine PK of free MT200605 and total MT200605 (unconjugated MT200605 and total MT200605 after enzymatic hydrolysisof MT200605 glucuronide conjugate metabolits by β-glucuronidase) (SAD)
Time frame: Up to 2 Days (the urine PK analysis only for 4th Corhort at SAD stage)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RuiHua Dong, PhD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT200605 for Injection in people with Healthy, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events（AEs) (time frame: From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.