Parkinson's DiseasePhase 1NCT05844787
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
A Phase 1 study testing MT101-5 in people with Parkinson's Disease, run by Mthera Pharma Co., Ltd. at 1 site in United States.
Trial summary
The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on: Incidence of Dose Limiting Toxicities (DLTs) Incidence of Treatment-Emergent Adverse… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MT101-5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 23 Feb 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- Age:
- SAD \& Food Interaction: Healthy male and female subjects, 18 to 45 years of age, inclusive.
- MAD: Elderly healthy male and female subjects ≥ 65 years of age
- BMI:
- SAD \& Food Interaction: The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 50 kg.
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- MAD: The subject has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and weighs at least 50 kg.
- The subject is in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram [ECG], vital signs, and clinical laboratory results at screening).
- The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
- The subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
- The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee.
- Negative pregnancy test for female subjects of childbearing potential. Women of childbearing potential (WOCBP) and Women of non-childbearing potential are eligible to participate. Both women of childbearing potential and women of non-childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 90 days after taking the last dose of MT101-5).
- Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (e.g., diaphragm, cervical cap, male condom, and female condom and spermicidal foam, sponges, and film) (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile at least three months before screening (confirmed by study doctor) or 2 years post-menopausal (patient reported) confirmed with FSH/estradiol levels at screening. All male subjects/partners must agree to consistently and correctly use a condom for the duration of the study and for 90 days after taking the study drug. In addition, subjects may not donate sperm for the duration of the study and for 90 days after taking study drug.
Who cannot join
- Subjects will be eligible for enrollment in the study only if they meet NONE of the following criteria:
- The subject has a history of severe allergic or anaphylactic reactions.
- The subject has a known allergy or hypersensitivity to any component of the formulation.
- The subject has a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
- The subject has a history of any malignant disease.
- The subject has a history of more than one herpes zoster episode or multimetameric herpes zoster.
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- The subject has a history of an opportunistic infection (e.g. cytomegalovirus, pneumocystis carinii, aspergillosis, clostridium difficile).
- The subject has a history of or ongoing chronic or recurrent infectious disease (e.g. infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
- The subject has had major trauma or surgery in the 2 months before screening or at any time between screening and check-in.
- The subject has had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (e.g., mild rhinorrhea), untreated oral/dental abnormalities (e.g. untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin.
- The subject has clinically significant abnormal ECG findings at screening, check-in visits, or predose, as determined by the Investigator.
- The subject has a supine blood pressure measurement outside the ranges of the below at screening, check-in, or predose. Note: If either value is out of the range, blood pressure measurements may be repeated in the supine position at intervals of 5 to 10 minutes up to 3 times. If the mean systolic or diastolic measurement continues to exceed the stated limits, the subject will be excluded.
- SAD: Ranges 90 to 140 mm Hg systolic or 45 to 90 mm Hg diastolic (measured after a rest of at least 5 minutes)
- MAD: Ranges 90 to 150 mm Hg systolic or 45 to 95 mm Hg diastolic (measured after a rest of at least 5 minutes)
- The subject has a pulse of fewer than 45 beats per minute (bpm) or greater than 100 bpm (measured after a rest of at least 5 minutes) at screening, check-in, or predose.
- The subject tests positive for tuberculosis (TB) at screening by the QuantiFERON-TB Gold Test, or has a history of latent, inadequately treated, or active TB.
- The subject has a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.
- The subject has used prescription or over-the-counter (OTC) medication (other than ≤2 g/day paracetamol [acetaminophen] or ≤800 mg/day ibuprofen), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever is longer.
- The subject has participated in another clinical study of a new investigational drug or has received an investigational drug within the 3 months or 5 half-lives (if available) before study drug administration, whichever is longer.
- The subject has had a loss of more than 400 mL of blood (e.g. a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before check-in, or plans to donate blood during the study or within 3 months after the study.
- The subject has a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1 single shot of spirits. The subject will be required to abstain from alcohol consumption 48 hours prior to screening or check-in.
- Current smokers and those who have smoked within the last 2 years. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
- The subject has a positive test for alcohol or drugs of abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) at screening or check-in.
- The subject is unable to participate in, or successfully complete, the study, in the opinion of their general practitioner or the investigator, because the subject is any of the following:
- mentally or legally incapacitated, or unable to give consent for any reason
- in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution
- unable to be contacted in case of emergency
- unlikely to cooperate or comply with the clinical study protocol or is unsuitable for any other reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, 1nc.
Secaucus, New Jersey, 07094
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on:
- Incidence of Dose Limiting Toxicities (DLTs)
- Incidence of Treatment-Emergent Adverse Events (TEAEs).
- Incidence of withdrawals due to Adverse Events (AEs).
- Change/shifts in laboratory values. Change in vital signs.
- Change in Electrocardiogram (ECG) parameters.
- Changes in physical examination findings
Read the detailed description
SAD Phase including Food Interaction:
Subjects will be assigned to one of up to five MT101-5 treatment cohorts and will be randomly assigned 6:2 within their cohort to receive MT101-5 or placebo. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study.
For the Food Interaction phase, on Day 1 following an overnight fast of at least 10 hours, the study subjects should start their standardized high-fat breakfast meal 30 minutes before administration of the drug product. Trial subjects should eat this meal in 30 minutes or less. Subjects will be administered MT101-5 or placebo as an oral tablet 30 minutes after start of intake of a standardized high-fat breakfast with 240 mL (8 fluid ounces) of water. Additional water is allowed ad lib except for 1 hour before and 1 hour after drug administration. No food is allowed for at least 4 hours after the dose.
MAD Phase:
Subjects will be randomly assigned 6:2 to receive MT101-5 or placebo once daily for 7 days. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study. The same will be followed for days 2-7.
- Conditions
- Parkinson's Disease
- Being tested
- MT101-5
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT101-5Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| SAD Phase | Experimental | SAD Phase: including Food Interaction - Blinding and Randomization: This is a randomized, double-blind, placebo-controlled, sentinel design, dose-escalating study with 40 healthy volunteers. Subjects will be assigned to 1 of up to 5 cohorts and will be randomized within each cohort to MT101-5 or placebo, as follows:
* cohort 1: 100 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo)
* cohort 2: 150 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo)
* cohort 3: 300 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo)
* cohort 4: 450 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo)
* cohort 5: 600 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) Receives: Drug: MT101-5 |
| Food Interaction Phase | Experimental | Food Interaction Phase: Following the completion of the SAD phase, if study stopping criteria (SSC) is not met, then subjects in cohort 5 will cross-over to the fed part of the study following a 7 day washout period. If SSC is achieved in the SAD phase, then the previous dose will be in the Food Interaction phase. Receives: Drug: MT101-5 |
| MAD Phase | Experimental | MAD Phase; Blinding and Randomization: This is a randomized, double-blind, placebo-controlled study in approximately 8 elderly healthy volunteers. If study stopping criteria (SSC) is not met in the SAD phase, then subjects will be assigned to the cohort 5 dose. If SSC is achieved in the SAD phase, then the previous dose will be used as the cohort in the MAD phase Receives: Drug: MT101-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
Any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as > Grade 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), where applicable, deemed by the investigator as at least "possibly, probably or definitely related" to the drug but unrelated to concurrent illness, or concomitant medications.
Measured: Day 1 through 7 days after the last study drug administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An adverse event may or may not be related to the study treatment.
Measured: Day 1 through 7 days after the last study drug administration
Incidence of withdrawals due to Adverse Events (AEs)
Incidence of withdrawals due to Adverse Events (AEs) defined above
Measured: Day 1 through 7 days after the last study drug administration
Change in complete blood count test
Measured: Change from baseline to day 7 after the first study drug administration
Change in comprehensive metabolic panel test
Measured: Change from baseline to day 7 after the first study drug administration
Change in urinalysis test
Measured: Change from baseline to day 7 after the first study drug administration
Change in pregnancy test
Measured: Change from baseline to day 7 after the first study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Measured: Change from pre-dose to 96 hours after last study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Measured: Change from pre-dose to day 7 after the last study drug administration
Change of pulse
Measured: Change from pre-dose to 96 hours after last study drug administration
Change of pulse
Measured: Change from pre-dose to day 7 after the last study drug administration
Change of temperature
Measured: Change from pre-dose to 96 hours after last study drug administration
Change of temperature
Measured: Change from pre-dose to day 7 after the last study drug administration
Change of respiratory rate
Measured: Change from pre-dose to 96 hours after last study drug administration
Change of respiratory rate
Measured: Change from pre-dose to day 7 after the last study drug administration
ECG ventricular rate (beats per minute)
Measured: At pre-dose
ECG ventricular rate (beats per minute)
Measured: 96 hours after study drug administration
ECG ventricular rate (beats per minute)
Measured: On day 7 after the last study drug administration
PR interval (msec)
Measured: At pre-dose
PR interval (msec)
Measured: 96 hours after study drug administration
PR interval (msec)
Measured: On day 7 after the last study drug administration
QRS interval (msec)
Measured: At pre-dose
QRS interval (msec)
Measured: 96 hours after study drug administration
QRS interval (msec)
Measured: On day 7 after the last study drug administration
QT interval (msec)
Measured: At pre-dose
QT interval (msec)
Measured: 96 hours after study drug administration
QT interval (msec)
Measured: On day 7 after the last study drug administration
QTc interval (msec)
Measured: At pre-dose
QTc interval (msec)
Measured: 96 hours after study drug administration
QTc interval (msec)
Measured: On day 7 after the last study drug administration
Maximum observed plasma drug concentration (Cmax)
Measured: 0-96 hours
Apparent terminal elimination half-life (t1/2)
Measured: 0-96 hours
Time to maximum observed plasma drug concentration (Tmax)
Measured: 0-96 hours
Area under the plasma drug concentration-time curve (AUC)
Measured: 0-96 hours
Percentage of AUC0-∞ extrapolated from Tlast to infinity (AUCext)
Measured: 0-96 hours
Apparent plasma clearance (CL/F)
Measured: 0-96 hours
Apparent Volume of distribution (Vz/F)
Measured: 0-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start11 Jul 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Sequential
- Model description
- Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mthera Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844787
- Sponsor's protocol ID
- MT101-PD-001
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05844787
- Acronym / sponsor ID
- MT101-PD-001
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mthera Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 6 May 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 primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on:
- Incidence of Dose Limiting Toxicities (DLTs)
- Incidence of Treatment-Emergent Adverse Events (TEAEs).
- Incidence of withdrawals due to Adverse Events (AEs).
- Change/shifts in laboratory values. Change in vital signs.
- Change in Electrocardiogram (ECG) parameters.
- Changes in physical examination findings
Detailed description
SAD Phase including Food Interaction:
Subjects will be assigned to one of up to five MT101-5 treatment cohorts and will be randomly assigned 6:2 within their cohort to receive MT101-5 or placebo. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study.
For the Food Interaction phase, on Day 1 following an overnight fast of at least 10 hours, the study subjects should start their standardized high-fat breakfast meal 30 minutes before administration of the drug product. Trial subjects should eat this meal in 30 minutes or less. Subjects will be administered MT101-5 or placebo as an oral tablet 30 minutes after start of intake of a standardized high-fat breakfast with 240 mL (8 fluid ounces) of water. Additional water is allowed ad lib except for 1 hour before and 1 hour after drug administration. No food is allowed for at least 4 hours after the dose.
MAD Phase:
Subjects will be randomly assigned 6:2 to receive MT101-5 or placebo once daily for 7 days. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study. The same will be followed for days 2-7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study.
| Arm | Type | Receives |
|---|---|---|
| SAD Phase | Experimental | Drug: MT101-5SAD Phase: including Food Interaction - Blinding and Randomization: This is a randomized, double-blind, placebo-controlled, sentinel design, dose-escalating study with 40 healthy volunteers. Subjects will be assigned to 1 of up to 5 cohorts and will be randomized within each cohort to MT101-5 or placebo, as follows: * cohort 1: 100 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) * cohort 2: 150 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) * cohort 3: 300 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) * cohort 4: 450 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) * cohort 5: 600 mg (8 subjects total; 6 receiving MT101-5, 2 receiving placebo) |
| Food Interaction Phase | Experimental | Drug: MT101-5Food Interaction Phase: Following the completion of the SAD phase, if study stopping criteria (SSC) is not met, then subjects in cohort 5 will cross-over to the fed part of the study following a 7 day washout period. If SSC is achieved in the SAD phase, then the previous dose will be in the Food Interaction phase. |
| MAD Phase | Experimental | Drug: MT101-5MAD Phase; Blinding and Randomization: This is a randomized, double-blind, placebo-controlled study in approximately 8 elderly healthy volunteers. If study stopping criteria (SSC) is not met in the SAD phase, then subjects will be assigned to the cohort 5 dose. If SSC is achieved in the SAD phase, then the previous dose will be used as the cohort in the MAD phase |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- Age:
- BMI:
- The subject is in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram [ECG], vital signs, and clinical laboratory results at screening).
- The subject is able to understand the nature of the study and any potential hazards associated with participating in it.
Key exclusion criteria (28 listed)
- Subjects will be eligible for enrollment in the study only if they meet NONE of the following criteria:
- The subject has a history of severe allergic or anaphylactic reactions.
- The subject has a known allergy or hypersensitivity to any component of the formulation.
- The subject has a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
- The subject has a history of any malignant disease.
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 |
|---|---|---|
| MT101-5Tablet | Drug | Food Interaction Phase, MAD Phase, SAD Phase |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Day 1 through 7 days after the last study drug administration
Any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as > Grade 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), where applicable, deemed by the investigator as at least "possibly, probably or definitely related" to the drug but unrelated to concurrent illness, or concomitant medications.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through 7 days after the last study drug administration
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An adverse event may or may not be related to the study treatment.
Incidence of withdrawals due to Adverse Events (AEs)
Time frame: Day 1 through 7 days after the last study drug administration
Incidence of withdrawals due to Adverse Events (AEs) defined above
Change in complete blood count test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in comprehensive metabolic panel test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in urinalysis test
Time frame: Change from baseline to day 7 after the first study drug administration
Change in pregnancy test
Time frame: Change from baseline to day 7 after the first study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of pulse
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of pulse
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of temperature
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of temperature
Time frame: Change from pre-dose to day 7 after the last study drug administration
Change of respiratory rate
Time frame: Change from pre-dose to 96 hours after last study drug administration
Change of respiratory rate
Time frame: Change from pre-dose to day 7 after the last study drug administration
ECG ventricular rate (beats per minute)
Time frame: At pre-dose
ECG ventricular rate (beats per minute)
Time frame: 96 hours after study drug administration
ECG ventricular rate (beats per minute)
Time frame: On day 7 after the last study drug administration
PR interval (msec)
Time frame: At pre-dose
PR interval (msec)
Time frame: 96 hours after study drug administration
PR interval (msec)
Time frame: On day 7 after the last study drug administration
QRS interval (msec)
Time frame: At pre-dose
QRS interval (msec)
Time frame: 96 hours after study drug administration
QRS interval (msec)
Time frame: On day 7 after the last study drug administration
QT interval (msec)
Time frame: At pre-dose
QT interval (msec)
Time frame: 96 hours after study drug administration
QT interval (msec)
Time frame: On day 7 after the last study drug administration
QTc interval (msec)
Time frame: At pre-dose
QTc interval (msec)
Time frame: 96 hours after study drug administration
QTc interval (msec)
Time frame: On day 7 after the last study drug administration
Maximum observed plasma drug concentration (Cmax)
Time frame: 0-96 hours
Apparent terminal elimination half-life (t1/2)
Time frame: 0-96 hours
Time to maximum observed plasma drug concentration (Tmax)
Time frame: 0-96 hours
Area under the plasma drug concentration-time curve (AUC)
Time frame: 0-96 hours
Percentage of AUC0-∞ extrapolated from Tlast to infinity (AUCext)
Time frame: 0-96 hours
Apparent plasma clearance (CL/F)
Time frame: 0-96 hours
Apparent Volume of distribution (Vz/F)
Time frame: 0-96 hours
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 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MT101-5 in people with Parkinson's Disease, run by Mthera Pharma 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 13 inclusion and 28 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 6 May 2023. 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?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: Day 1 through 7 days after the last study drug administration). The study lists 37 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 6 May 2023.