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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055403
• Other study ID #: M201-A-CT-001
• Status: Completed
• Phase: Phase 1
• Start date: February 17, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: November 2021
• Source: Kitasato University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not Provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
• Placebo
Saline Placebo for M201-A Route of administration: continuous intravenous injection

Locations

Country	Name	City	State
Japan	Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE	Sagamihara	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Yuji KUMAGAI	Aetas Pharma Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics-AUC0-8	Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-8) of M201-A	Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetics-E0-24	Amount of drug excreted in urine from time zero to 24hour of M201-A	up to 24 hours
Secondary	Pharmacokinetics-Ae	Urinary excretion rate of M201-A	up to 24 hours