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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: M201-A Injection; Drug: Placebo

• Registration Number: NCT03055403
• Lead Sponsor: Yuji KUMAGAI

Brief Summary

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

Not Provided

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-02-17
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-28
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M201-A Injection	M201-A Injection	Active Substance: M201-A Route of administration: continuous intravenous injection
Placebo	Placebo	Saline Placebo for M201-A Route of administration: continuous intravenous injection

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Throughout the study duration (up to day8)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE; 🇯🇵 Sagamihara, Kanagawa, Japan