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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: belatacept

• Registration Number: NCT03375138
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-04
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-15
• Primary Completion: 2018-05-08
• Study Completion: 2019-04-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Process E PPQ belatacept	belatacept	10 mg/kg, single dose by intravenous (IV) infusion.
Process C belatacept	belatacept	10 mg/kg, single dose by intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).	Up to day 57	Measured by plasma concentration.
Maximum observed serum concentration (Cmax).	Up to day 57	Measured by plasma concentration.

Secondary Outcome Measures

Name	Time	Method
Number of participants with electrocardiogram (ECG) abnormalities.	Up to 71 days.
Incidence of Adverse Events (AEs) leading to discontinuation.	Up to 71 days.	Safety and tolerability as measured by incidence of AEs leading to discontinuation.
Number of participants with vital sign abnormalities.	Up to 71 days.
Incidence of non-serious Adverse Events (AEs).	Up to 71 days.	Safety and tolerability as measured by incidence of non-serious AEs.
Incidence of Serious Adverse Events (SAEs).	Up to 71 days.	Safety and tolerability as measured by incidence of SAEs.
Number of participants with clinical laboratory abnormalities.	Up to 71 days.
Number of participants with physical examination abnormalities.	Up to 71 days.

Trial Locations

Locations (2)

PPD Austin Clinic; 🇺🇸 Austin, Texas, United States

Covance, Inc.; 🇺🇸 Dallas, Texas, United States