Phase 1 N=47 Randomized Single-blind Supportive Care

Subcutaneous Pharmacokinetics of Belatacept

Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT00569803 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Maximum Observed Serum Concentration (Cmax) of Belatacept — 3.9; 6.2; 8.5; 11.1 ug/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: belatacept (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Serum Concentration (Cmax) of Belatacept	3.9; 6.2; 8.5; 11.1; 14.5; 14.5	—
PRIMARY Time of Maximum Observed Serum Concentration (Tmax) of Belatacept	84; 60; 96; 60; 60; 72	—
PRIMARY 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	2587; 1848; 2371; 2703; 2650; 2193	—
PRIMARY Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept	2639; 1851; 2380; 2719; 2666; 2201	—
PRIMARY Serum Half-life (T-HALF) of Belatacept	112; 100; 135; 158; 161; 150	—
PRIMARY Apparent Total Body Clearance (CLT/F) of SC Belatacept	47.4; 67.5; 52.5; 46.0; 46.9; 56.8	—
PRIMARY Total Body Clearance (CLT) of IV Belatacept	41.2	—
PRIMARY Volume of Distribution at Steady State (VSS) for IV Belatacept	7.3	—
PRIMARY Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept	10.79; 15.30; 14.12; 12.75; 13.34; 15.82	—
SECONDARY Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption	898; 1002; 906; 1007	—
SECONDARY Number of Participants With Vital Sign Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Injection Site Reactions	0; 1; 1; 0; 1; 0	—
SECONDARY Number of Participants With Physical Examination Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities	0; 0; 2; 0; 1; 0	—
SECONDARY Number of Participants With Marked Hematology Laboratory Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Marked Serum Chemistry Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Marked Laboratory Abnormalities	1; 1; 0; 0; 0; 0	—
SECONDARY Number of Participants With Positive Immunogenicity to Belatacept	4; 5; 5; 5; 5; 5	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Men and women ages 18 to 65 years old
Subjects must weigh less than or equal to 100 kg

Exclusion Criteria

Inability to tolerate injections or IV infusions
autoimmune disorders
TB
herpes
HCV
HBV
HIV
bacterial or viral infection
history of cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00569803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.