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

NCT04464681 | Completed Phase 1

• 1 other identifier: M201-A-CT-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

M201-A Injection

EXPERIMENTAL

Active Substance: M201-A Route of administration: continuous intravenous injection

Drug: M201-A Injection

Placebo

PLACEBO COMPARATOR

Placebo: M201-A Placebo Route of administration: continuous intravenous injection

Drug: Placebo

Interventions

M201-A Injection DRUG

Active Substance: M201-A Route of administration: continuous intravenous injection

M201-A Injection

Placebo DRUG

Placebo: M201-A Placebo Route of administration: continuous intravenous injection

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kitasato University: lead
• Aetas Pharma Co. Ltd.: collaborator

Study Sites (1)

Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL

Tokyo, 108-8642, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trial Center

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 9, 2020
• Study Start: March 30, 2020
• Primary Completion: November 28, 2020
• Study Completion: November 30, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

JP (1)