Clinical Trials/NCT03055403

NCT03055403

Completed

Phase 1

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

Yuji KUMAGAI1 site in 1 country40 target enrollmentFebruary 17, 2017

ConditionsHealthy Volunteers

InterventionsM201-A Injection Placebo

DrugsM201-A Injection Placebo

Overview

Phase: Phase 1
Intervention: M201-A Injection
Conditions: Healthy Volunteers
Sponsor: Yuji KUMAGAI
Enrollment: 40
Locations: 1
Primary Endpoint: Number of participants with adverse events as a measure of safety and tolerability
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 17, 2017

End Date

November 28, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Yuji KUMAGAI

Responsible Party

Sponsor Investigator

Principal Investigator

Yuji KUMAGAI

Professor

Kitasato University

Eligibility Criteria

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

Arms & Interventions

M201-A Injection

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

Intervention: M201-A Injection

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Number of participants with adverse events as a measure of safety and tolerability

Time Frame: 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 Outcomes

Pharmacokinetics-AUC0-∞(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion 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)
Pharmacokinetics-E0-24(up to 24 hours)
Pharmacokinetics-Cmax(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion 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)
Pharmacokinetics-t1/2(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion 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)
Pharmacokinetics-AUC0-t(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)
Pharmacokinetics-Ae(up to 24 hours)
Pharmacokinetics-Vd(Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A)