NCT03714022

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

A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will be admitted to the clinical facility the day prior to dosing (Day -1) and will be confined until at least 24 hours post-dose. On Day 1, eligible participants will be randomized in a 1:1 ratio to either Treatment A or Treatment B. The randomization will be stratified by weight categories: \>= 60 to \< 70 kg, \>= 70 to \< 80 kg, \>= 80 to \< 90 kg, and \>= 90 to \<= 100 kg.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	Participants will receive abatacept at a single dose 750 mg as IV infusion.

Timeline

• Start date: 2018-11-09
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2018-10-22
• Last updated: 2021-01-07
• Results posted: 2021-01-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study