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

Bristol-Myers Squibb84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

belataceptDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

PPD Austin Clinic

Austin, Texas, United States

Covance, Inc.

Dallas, Texas, United States

Outcomes

Primary Outcomes

Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).

Measured by plasma concentration.

Time frame: Up to day 57

Maximum observed serum concentration (Cmax).

Measured by plasma concentration.

Time frame: Up to day 57

Secondary Outcomes

Incidence of non-serious Adverse Events (AEs).

Safety and tolerability as measured by incidence of non-serious AEs.

Time frame: Up to 71 days.

Incidence of Serious Adverse Events (SAEs).

Safety and tolerability as measured by incidence of SAEs.

Time frame: Up to 71 days.

Incidence of Adverse Events (AEs) leading to discontinuation.

Safety and tolerability as measured by incidence of AEs leading to discontinuation.

Time frame: Up to 71 days.

Number of participants with vital sign abnormalities.

Time frame: Up to 71 days.

Number of participants with physical examination abnormalities.

Time frame: Up to 71 days.

Number of participants with clinical laboratory abnormalities.

Time frame: Up to 71 days.

Number of participants with electrocardiogram (ECG) abnormalities.

Time frame: Up to 71 days.

Data from ClinicalTrials.gov

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