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Immunosuppressant

Belatacept 125 mg Intravenous Infusion for Transplant

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Awards & highlights

Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
Apparent Total Body Clearance (CLT/F) of SC Belatacept
+6 more
Secondary study objectives
Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
Number of Participants With Electrocardiogram (ECG) Abnormalities
Number of Participants With Injection Site Reactions
+6 more

Trial Design

8Treatment groups
Active Control
Placebo Group
Group I: Belatacept 125 mg Intravenous InfusionActive Control1 Intervention
125 mg Belatacept intravenous (IV) injection
Group II: Belatacept 50 mg Subcutaneous InjectionActive Control1 Intervention
Belatacept 50 mg subcutaneous (SC) injection
Group III: Belatacept 100 mg Subcutaneous InjectionActive Control1 Intervention
Belatacept 100 mg SC injection
Group IV: Belatacept 125 mg Subcutaneous InjectionActive Control1 Intervention
Belatacept 125 mg SC injection
Group V: Belatacept 150 mg Subcutaneous InjectionsActive Control1 Intervention
2 SC injections of 75 mg Belatacept
Group VI: Belatacept 200 mg Subcutaneous InjectionsActive Control1 Intervention
2 SC injections of 100 mg Belatacept
Group VII: Belatacept 250 mg Subcutaneous InjectionsActive Control1 Intervention
2 SC injections of 125 mg Belatacept
Group VIII: PlaceboPlacebo Group1 Intervention
SC injection of placebo solution

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,125,001 Total Patients Enrolled
~9 spots leftby Oct 2025
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