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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 December 2021
• Main ID: NCT03055403
• Date of registration: 10/02/2017
• Prospective Registration: Yes
• Primary sponsor: Yuji KUMAGAI
• Public title: First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
• Scientific 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
• Date of first enrolment: February 17, 2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03055403
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 39 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: M201-A Injection

Drug: Placebo

Primary Outcome(s)

Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Throughout the study duration (up to day8)]

Secondary Outcome(s)

Pharmacokinetics-Ae [Time Frame: up to 24 hours]

Pharmacokinetics-AUC0-24 [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-AUC0-8 [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-Tmax [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-AUC0-t [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-Cmax [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-Vd [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-CL [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Pharmacokinetics-E0-24 [Time Frame: up to 24 hours]

Pharmacokinetics-t1/2 [Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A]

Secondary ID(s)

M201-A-CT-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aetas Pharma Co. Ltd.