Status:
COMPLETED
A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03375138
Start Date
December 4 2017
End Date
April 2 2019
Last Update
July 24 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Austin Clinic
Austin, Texas, United States, 78744
2
Covance, Inc.
Dallas, Texas, United States, 75247