drugset / Trial / NCT03714022

A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes

NCT03714022

Phase 1 Completed 140 enrolled Bristol-Myers Squibb
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

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 750 mg Intravenous

Indications