A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: belatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03375138

IM103-399

Details and patient eligibility

About

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed informed consent form.
• Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
• Weight between 60.0 to 100.0 kg, inclusive.
• Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
• Women must not be breastfeeding.
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.

Exclusion criteria

• Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
• History of shingles (herpes zoster).
• Personal or strong family history of cancer.
• Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
• Any known or suspected autoimmune disorder.

Other protocol defined inclusion/exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Process E PPQ belatacept

Experimental group

Description:

10 mg/kg, single dose by intravenous (IV) infusion.

Treatment:

Drug: belatacept

Process C belatacept

Experimental group

Description:

10 mg/kg, single dose by intravenous (IV) infusion.

Treatment:

Drug: belatacept