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

NCT03055403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-11-30

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

M201-A Injection

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Aetas Pharma Co. Ltd.

    collaborator INDUSTRY

  • Yuji KUMAGAI

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-17
Primary Completion
2017-11-28
Completion
2017-11-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055403 on ClinicalTrials.gov