CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 223 enrolled
Drug / intervention
Abatacept (BMS-188667)biological
Likely dose
Abatacept (BMS-188667) 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01439204
NCT01439204Phase 1Completed

A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects

Bristol-Myers Squibb·interventional·Posted Sep 23, 2011·Updated Mar 19, 2014

In Brief

A Phase 1 clinical trial evaluating Abatacept (BMS-188667) for Rheumatoid Arthritis. Completed, enrolled 223 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.8 years ago

Interventions

Abatacept (BMS-188667)biological

Solution for injection, Intravenous, 750 mg, Single dose, 1 day,