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

• Status: Completed
• Trial end date: 2019-04-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

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.