CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 140 enrolled
Drug / intervention
Abataceptdrug
Likely dose
Abatacept 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/NCT03714022
NCT03714022Phase 1Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Oct 22, 2018·Updated Jan 7, 2021

In Brief

A Phase 1 clinical trial evaluating Abatacept for Rheumatoid Arthritis. Completed, enrolled 140 participants across 2 sites.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartNov 9, 2018
Primary CompletionApr 2, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.7 years ago

Interventions

Abataceptdrug

Participants will receive abatacept at a single dose 750 mg as IV infusion.