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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03375138

Run by

Bristol-Myers Squibb

People needed

84

Starts

2017-12-04

Expected to finish

2019-04-02

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD Austin Clinic — Austin, Texas, United States
• Covance, Inc. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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