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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: belatacept


Participation Criteria
=================
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. Other protocol defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers