Trials / Completed
CompletedNCT02927353
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Meiji Seika Pharma Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 39 Years
- Healthy volunteers
- Accepted
Summary
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DMB-3113 | subcutaneously injected in a single dose of 40 mg. |
| DRUG | Adalimumab | subcutaneously injected in a single dose of 40 mg. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-01-17
- Completion
- 2017-01-17
- First posted
- 2016-10-07
- Last updated
- 2017-08-22
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02927353. Inclusion in this directory is not an endorsement.