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Active, Not Recruiting

A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes - IM103-399

Updated: 24 May, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-55

    Age Range

  • 2

    Location(s)

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Process C belatacept
Drug: belatacept
Experimental: Process E PPQ belatacept
Drug: belatacept

Key Eligibility 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.

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us