Trials / Completed
CompletedNCT04464681
Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
A Randomized, Double-Blind, Placebo-Controlled, Multiple Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Kitasato University · Academic / Other
- Sex
- Male
- Age
- 20 Years – 49 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-03-30
- Primary completion
- 2020-11-28
- Completion
- 2020-11-30
- First posted
- 2020-07-09
- Last updated
- 2021-08-31
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04464681. Inclusion in this directory is not an endorsement.