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

NCT ID: NCT03375138

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2019-04-02

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/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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Process E PPQ belatacept

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

Group Type: EXPERIMENTAL

belatacept

Intervention Type: DRUG

Specified dose on specified days

Process C belatacept

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

Group Type: EXPERIMENTAL

belatacept

Intervention Type: DRUG

Specified dose on specified days

Interventions

belatacept

Specified dose on specified days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

PPD Austin Clinic

Austin, Texas, United States

Covance, Inc.

Dallas, Texas, United States

Countries

United States

Related Links

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

IM103-399

Identifier Type: -

Identifier Source: org_study_id