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

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

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.

Study Overview

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

Detailed Description

Not Provided

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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; Saline Placebo for M201-A Route of administration: continuous intravenous injection	Drug: Placebo; Saline Placebo for M201-A 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	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

Collaborators and Investigators

• Sponsor: Yuji KUMAGAI
• Collaborators: Aetas Pharma Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2017
• Primary Completion (ACTUAL): November 28, 2017
• Study Completion (ACTUAL): November 28, 2017

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (ACTUAL): February 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M201-A-CT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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