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Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects

NCT04464681 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-08-31

No results posted yet for this study

Summary

This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple 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

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

Sponsors & Collaborators

  • Aetas Pharma Co. Ltd.

    collaborator INDUSTRY

  • Kitasato University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-11-28
Completion
2020-11-30

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 NCT04464681 on ClinicalTrials.gov