First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.

Detailed Description
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Not Provided

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: M201-A Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: Japanese Healthy Male subjects Age 20 to less than 40 years of age Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 Written informed consent must be obtained on a voluntary basis before any assessment is performed. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial Past medical history of cancer, cerebral infarction or cardiac infarction Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials QTcF > 450ms at the screening examination NT-proBNP > 125 pg/mL at the screening examination Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M201-A Injection<br>Active Substance: M201-A Route of administration: continuous intravenous injection | Drug: M201-A Injection<br>* Active Substance: M201-A Route of administration: continuous intravenous injection<br>|
| Placebo Comparator: Placebo<br>Saline Placebo for M201-A Route of administration: continuous intravenous injection | Drug: Placebo<br>* Saline Placebo for M201-A Route of administration: continuous intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability | adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures. | Throughout the study duration (up to day8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics-Cmax | Observed maximum plasma concentration (Cmax) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-Tmax | Time to Cmax (Tmax) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-AUC0-24 | Area under the plasma concentration-time curve from time zero to 24hour of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-AUC0-t | -Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-AUC0-∞ | Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-t1/2 | Elimination half-life (t1/2) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-CL | Apparent clearance of drug from plasma (CL) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-Vd | Apparent volume of distribution during the terminal phase (Vd) of M201-A | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | 
| Pharmacokinetics-E0-24 | Amount of drug excreted in urine from time zero to 24hour of M201-A | up to 24 hours | 
| Pharmacokinetics-Ae | Urinary excretion rate of M201-A | up to 24 hours |