Trials / Completed
CompletedNCT05981976
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Abatacept | Specified dose on specified days |
Timeline
- Start date
- 2023-08-18
- Primary completion
- 2023-12-14
- Completion
- 2023-12-14
- First posted
- 2023-08-08
- Last updated
- 2024-07-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05981976. Inclusion in this directory is not an endorsement.