Subcutaneous Pharmacokinetics of Belatacept

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Transplantation

Treatments: Drug: Placebo; Drug: belatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569803

IM103-046

Details and patient eligibility

About

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

Enrollment: 153 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 8 patient groups, including a placebo group

Belatacept 50 mg Subcutaneous Injection

Active Comparator group

Description:

Belatacept 50 mg subcutaneous (SC) injection

Treatment:

Drug: belatacept

Belatacept 100 mg Subcutaneous Injection

Active Comparator group

Description:

Belatacept 100 mg SC injection

Treatment:

Drug: belatacept

Belatacept 125 mg Subcutaneous Injection

Active Comparator group

Description:

Belatacept 125 mg SC injection

Treatment:

Drug: belatacept

Belatacept 150 mg Subcutaneous Injections

Active Comparator group

Description:

2 SC injections of 75 mg Belatacept

Treatment:

Drug: belatacept

Belatacept 200 mg Subcutaneous Injections

Active Comparator group

Description:

2 SC injections of 100 mg Belatacept

Treatment:

Drug: belatacept

Belatacept 250 mg Subcutaneous Injections

Active Comparator group

Description:

2 SC injections of 125 mg Belatacept

Treatment:

Drug: belatacept

Belatacept 125 mg Intravenous Infusion

Active Comparator group

Description:

125 mg Belatacept intravenous (IV) injection

Treatment:

Drug: belatacept

Placebo

Placebo Comparator group

Description:

SC injection of placebo solution

Treatment:

Drug: Placebo