NCT02564497

A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Process E Belatacept
BIOLOGICAL	Process C Belatacept

Timeline

• Start date: 2015-10-02
• Primary completion: 2017-01-27
• Completion: 2017-01-27
• First posted: 2015-09-30
• Last updated: 2019-04-17
• Results posted: 2019-04-17

Locations

1 site across 1 country: United States