CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 153 enrolled
Drug / intervention
belatacept +1 moredrug
Likely dose
Belatacept single dose, 116 days durationAI-extracted
Key inclusion· 2
  • ✓Age 18 to 65 years old
  • ✓Body weight ≤100 kg
Key exclusion· 9
  • ✕Inability to tolerate injections or intravenous infusions
  • ✕Autoimmune disorders
  • ✕Tuberculosis
  • ✕Herpes infection

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

Search/NCT00569803
NCT00569803Phase 1Completed
CompareCT.gov

Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Bristol-Myers Squibb·interventional·Posted Dec 7, 2007·Updated Sep 22, 2016

In Brief

A Phase 1 clinical trial evaluating belatacept and Placebo for Transplantation. Completed, enrolled 153 participants across 1 site.

Detailed Summary

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2007
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.6 years ago

Interventions

belataceptdrug

single dose, 116 days

Placebodrug

Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)