Trials / Completed
CompletedNCT02923583
Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects
A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- Momenta Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | M834 | |
| BIOLOGICAL | US-Sourced Orencia® | |
| BIOLOGICAL | EU-Sourced Orencia® |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-07-21
- Completion
- 2017-07-21
- First posted
- 2016-10-04
- Last updated
- 2017-10-24
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02923583. Inclusion in this directory is not an endorsement.