At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 491 enrolled
Drug / intervention
Process E Belatacept +1 morebiological
Likely dose
Not stated in 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.
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
In Brief
A Phase 1 clinical trial evaluating Process E Belatacept and Process C Belatacept for Renal Transplantation. Completed, enrolled 491 participants across 1 site.
Detailed Summary
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionJan 2017
TodayJul 2026
First PostedSep 30, 2015
Enrollment StartOct 2, 2015
Primary CompletionJan 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.8 years ago
Interventions
Process E Belataceptbiological
Process C Belataceptbiological