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

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: belatacept

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Austin Clinic
    • Dallas, Texas, United States, 75247
      • Covance, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Process E PPQ belatacept; 10 mg/kg, single dose by intravenous (IV) infusion.	Drug: belatacept; Specified dose on specified days
Experimental: Process C belatacept; 10 mg/kg, single dose by intravenous (IV) infusion.	Drug: belatacept; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: IM103-399

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No