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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-02

Study Completion Date

2017-01-27

Brief Summary

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

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Process E Belatacept

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

Group Type OTHER

Process E Belatacept

Intervention Type BIOLOGICAL

Process C Belatacept

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

Group Type OTHER

Process C Belatacept

Intervention Type BIOLOGICAL

Interventions

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Process E Belatacept

Intervention Type BIOLOGICAL

Process C Belatacept

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes