A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

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 Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Subjects

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Biological: Process E Belatacept
* Biological: Process C Belatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Target population: Healthy males and females. Males and females, ages 18 to 55 years, inclusive. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test Women must not be breastfeeding Men and WOCBP must agree to follow instructions for contraception Exclusion Criteria: History of TB, malignancy, any other chronic or acute infecton or disease. History of acute or chronic medical illness Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population. History of allergy to belatacept or related compounds -

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Process E Belatacept<br>Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E | Biological: Process E Belatacept<br> <br> |
| Other: Process C Belatacept<br>Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C | Biological: Process C Belatacept<br> <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 (INF) of Belatacept. | (AUC[INF]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA) | Day 1 to Day 71 | 
| Maximum Observed Serum Concentration (Cmax) of Belatacept | Cmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in nanograms per milliliter. | Day 1 to Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Maximum Observed Serum Concentration (Tmax) | Tmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Tmax was measured in hours (h). | Day 1 to Day 71 | 
| Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T) | (AUC[0-T]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng.h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA) | Day 1 to Day 71 | 
| Total Body Clearance (CLT) | CLT was the volume of belatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). CLT was measured in liters per hour. | Day 1 to Day 71 | 
| Volume of Distribution at Steady State (Vss) |  | Day 1 to Day 71 | 
| Half Life (T-HALF) |  | Day 1 to Day 71 |