drugset / Trial / NCT03714022
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes
RandomizedParallel-groupOpen-labelTreatment
Summary
The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept drug product converted from drug substance by a new drug substance process (Treatment A) relative to the current drug substance process (Treatment B) following a single dose (750 mg) intravenous (IV) infusion in healthy participants.
Timeline
- Start
- 2018-11-09
- Primary completion
- 2019-04-02
- Completion
- 2019-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 750 mg | Intravenous |