A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

Summary

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

Timeline

Start

2017-12-04

Primary completion

2018-05-08

Completion

2019-04-02

Drugs

Indications

No indication recorded.