A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Transplantation

Treatments: Biological: Process E Belatacept; Biological: Process C Belatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564497

IM103-349

Details and patient eligibility

About

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

Enrollment: 491 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females, ages 18 to 55 years, inclusive.
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

1. History of TB, malignancy, any other chronic or acute infecton or disease.
2. History of acute or chronic medical illness
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to belatacept or related compounds -

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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491 participants in 2 patient groups

Process E Belatacept

Other group

Description:

Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E

Treatment:

Biological: Process E Belatacept

Process C Belatacept

Other group

Description:

Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C

Treatment:

Biological: Process C Belatacept