Multiple 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 is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple 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 (1)Japanese Healthy Male subjects (2)Age 20 to less than 50 years of age (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination (4)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: (1)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 (2)Past medical history of cancer, cerebral infarction or cardiac infarction (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation. (4)Presence or past history of epilepsy. (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials (6)heart rate(HR) >= 100 bpm at the screening examination (7)The corrected QT interval(QTcF) >= 440 ms at the screening examination (8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination (9)K<3.6 mEq/L at the screening examination (10)Past history or suspect of aldosteronism. (11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history (12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration. (14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication. (15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication. (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication. (17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study. (18)Subject who was administered M201-A in the past. (19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period. (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization. (21) Presence or past history of drug/alcohol abuse. (22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration. (23)Subject who investigator judges ineligible for other reasons

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 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: Sequential 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>Placebo: M201-A Placebo Route of administration: continuous intravenous injection | Drug: Placebo<br>* Placebo: M201-A Placebo 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 | Number of participants with 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 day 11 |