HealthyPhase 1NCT04116840
Single Ascending Dose Trial to Evaluate the Safety, Tolerability, PK, and PD of MT1002 for Injection
A Phase 1 study testing MT1002 for injection in people with Healthy, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
Trial summary
This is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following intravenous bolus/infusion ascending dose administration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT1002 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 27 Nov 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-60 years.
- Able and willing to give written informed consent.
- BMI between 18.0 and 34.0 kg/m2, inclusive.
- Subjects must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the last study visit).
- Women must be:
- not pregnant
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- not breast-feeding
- not planning to become pregnant during the study
- All females must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1. All women must agree to use an adequate method of contraception during the study and for 30 days following the end-of-study visit.
- Male subjects must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from clinic admission until 30 days following the end of study visit.
- Male subjects must agree to refrain from sperm donation from clinic admission until at least 30 days following the end of study visit.
Who cannot join
- Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the subject unsuitable for the study.
- Does not tolerate venepuncture or has poor venous access that would cause difficulty for collecting blood samples.
- Has participated in an investigational drug study and received investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit or who is currently participating in another clinical trial.
- Has experienced an acute illness within 14 days prior to the screening visit.
- Any clinically significant abnormalities in hematology, blood chemistry and/or urinalysis lab tests at screening or at D1.
- Known hypersensitivity to MT1002
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- 8. History of any drug hypersensitivity that would require urgent medical care 9. Use of aspirin or any non-steroidal anti-inflammatory drug within 14 days of Day -1 10. Any serum FSH result <40mIU/mL 11. History, symptoms, or signs of cardiovascular or cerebrovascular disease. 12. History, symptoms, or signs of severe hepatic impairment. 13. HbA1c >5.7% at Screening 14. History of excessive bleeding from an injury or after surgery or dental work.
- 15. History of heavy or long menstrual bleeding. 16. History of blood in urine or stool or history of black stools. 17. History of easy bruising. 18. PT or aPTT > upper limit of normal at Screening or Day -1. 19. Platelet count < lower limit of normal at Screening or Day -1 20. History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or breathalyzer alcohol test.
- 21. Positive urinary test for drugs of abuse and/or alcohol breath test at Screening and/or at check-in on Day -1.
- 22. Supine systolic blood pressure (BP) > 130 mm Hg, diastolic BP > 80 mm Hg, respiratory rate >20 breaths per minute, pulse >90 beats per minute, or temperature >37.5º at Screening.
- 23. Abnormal 12-lead ECG that may jeopardize the subject's safety to participate in this study or a screening 12-lead ECG demonstrating any one of the following: heart rate (HR) > 100 beats per minute (bpm), QRS > 120 milliseconds (msec), QTcF > 450 msec, or PR > 220 msec.
- 24. Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, or other medicinal products that lead to QT prolongation.
- 25. Any clinically significant alanine aminotransferase (ALT), alkaline phosphatase (AP), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) or bilirubin abnormalities judged by the Investigator or designee at Screening.
- 27. Tobacco or nicotine users except subjects who stopped using tobacco or nicotine 90 days or more before signing the informed consent.
- 28. Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human immunodeficiency virus (HIV) antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Sequential Parallel Group, Single Ascending Dose Following Intravenous Bolus/Infusion Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT1002 for Injection
This is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following intravenous bolus/infusion ascending dose administration.
Read the detailed description
An initial, single dose escalation study of MT1002 for injection for injection in heathy subjects will be performed to evaluate safety, pharmacokinetics, and pharmacodynamics after intravenous bolus and infusion administration.
A total of 36 subjects (6 subjects per cohort) in 6 dose levels . At each dose level, a single sentinel subject will be dosed first. Sentinel subjects will receive a phone call at 48 hours ±4 hours to inquire about their status. If no dose-limiting toxicity is observed for 48 hours post-dose, the remaining 5 subjects in that dose level will be treated.
- Conditions
- Healthy
- Being tested
- MT1002 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1002 for injectionDrug
Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| MT1002 for Injection | Experimental | Single Ascending Dose following Intravenous Bolus/Infusion Administration in Healthy Subjects Receives: Drug: MT1002 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Maximum observed concentration following intravenous bolus/infusion administration of MT1002 for injection
Measured: 24 hours
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Measured: 24 hours
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
Measured: 24 hours
AUC extrapolated to infinity (AUC0-∞)
AUC extrapolated to infinity (AUC0-∞)
Measured: 24 hours
Activated clotting time (ACT)
Activated clotting time (ACT)
Measured: 24 hours
Activated partial thromboplastin time (aPTT)
Activated partial thromboplastin time (aPTT)
Measured: 24 hours
International normalized ratio (INR)
International normalized ratio (INR)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start29 Apr 2019
- Primary completion1 Aug 2019
- Study completion27 Nov 2019
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MB, Principal investigator, Pharmaron CPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116840
- Sponsor's protocol ID
- MT1002-Ⅰ-C01
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 29 Jul 2022
- Results posted
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Sequential Parallel Group, Single Ascending Dose Following Intravenous Bolus/Infusion Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT1002 for Injection
- ClinicalTrials.gov ID
- NCT04116840
- Acronym / sponsor ID
- MT1002-Ⅰ-C01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 7 Oct 2019 (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.
This is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following intravenous bolus/infusion ascending dose administration.
Detailed description
An initial, single dose escalation study of MT1002 for injection for injection in heathy subjects will be performed to evaluate safety, pharmacokinetics, and pharmacodynamics after intravenous bolus and infusion administration.
A total of 36 subjects (6 subjects per cohort) in 6 dose levels . At each dose level, a single sentinel subject will be dosed first. Sentinel subjects will receive a phone call at 48 hours ±4 hours to inquire about their status. If no dose-limiting toxicity is observed for 48 hours post-dose, the remaining 5 subjects in that dose level will be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT1002 for Injection | Experimental | Drug: MT1002 for injectionSingle Ascending Dose following Intravenous Bolus/Infusion Administration in Healthy Subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female aged 18-60 years.
- Able and willing to give written informed consent.
- BMI between 18.0 and 34.0 kg/m2, inclusive.
- Subjects must be able to refrain from consuming xanthine, quinine and caffeine containing beverages, and must refrain from prolonged intensive physical exercise during the study (from 72 hours prior to dosing until the last study visit).
- Women must be:
Key exclusion criteria (15 listed)
- Any medical condition, clinical laboratory test or other reason which in the judgment of the Investigator or designee makes the subject unsuitable for the study.
- Does not tolerate venepuncture or has poor venous access that would cause difficulty for collecting blood samples.
- Has participated in an investigational drug study and received investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit or who is currently participating in another clinical trial.
- Has experienced an acute illness within 14 days prior to the screening visit.
- Any clinically significant abnormalities in hematology, blood chemistry and/or urinalysis lab tests at screening or at D1.
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 |
|---|---|---|
| MT1002 for injectionStudy drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours. | Drug | MT1002 for Injection |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: 24 hours
Maximum observed concentration following intravenous bolus/infusion administration of MT1002 for injection
Time to maximum concentration (Tmax)
Time frame: 24 hours
Time to maximum concentration (Tmax)
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
Time frame: 24 hours
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
AUC extrapolated to infinity (AUC0-∞)
Time frame: 24 hours
AUC extrapolated to infinity (AUC0-∞)
Activated clotting time (ACT)
Time frame: 24 hours
Activated clotting time (ACT)
Activated partial thromboplastin time (aPTT)
Time frame: 24 hours
Activated partial thromboplastin time (aPTT)
International normalized ratio (INR)
Time frame: 24 hours
International normalized ratio (INR)
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Mohamed Al-Ibrahim, MB principal investigator
Pharmaron CPC, Inc.
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 MT1002 for injection in people with Healthy, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
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 11 inclusion and 15 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 29 Jul 2022. 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 United States. 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. 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?
Maximum observed concentration (Cmax) (time frame: 24 hours). The study lists 7 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 29 Jul 2022.