Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: M201-A Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 108-8642
    • Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M201-A Injection; Active Substance: M201-A Route of administration: continuous intravenous injection	Drug: M201-A Injection; Active Substance: M201-A Route of administration: continuous intravenous injection
Placebo Comparator: Placebo; Placebo: M201-A Placebo Route of administration: continuous intravenous injection	Drug: Placebo; Placebo: M201-A Placebo Route of administration: continuous intravenous injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kitasato University
• Collaborators: Aetas Pharma Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): November 28, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M201-A-CT-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No