Dr. Reddy's Laboratories Limited
This is a randomised, double-blind, single dose, parallel groups study to compare the PK, immunogenicity, and safety of 3 abatacept products (DRL_AB, RP and RMP) in male NHV.
Rheumatoid Arthritis
Test Product
Reference product
Reference Medicinal Product
PHASE1
This will be a randomised, double-blind, single dose, parallel groups study to compare the PK, safety and immunogenicity of 3 abatacept products (DRL_AB, RP and RMP) in Male NHV. 330 subjects will be randomised 1:1:1 to receive a single 125 mg SC dose of abatacept administered as either DRL_AB or RP or RMP. A BSSR (blinded sample size re-estimation) will be performed when the data from approximately 132 NHV (44 per arm) is available. Study randomisation will be stratified by body weight (lower half of the allowed range and upper half of the allowed range i.e. 60.0 to \<80 kg and ≥80.0 to 100.0 Kg).
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 330 participants |
Masking : | DOUBLE |
Primary Purpose : | OTHER |
Official Title : | A Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study of DRL_AB, US Licensed Reference Abatacept (Orencia®) and EU Approved Reference (Orencia®), Administered by the Subcutaneous Route to Male Normal Healthy Volunteers |
Actual Study Start Date : | 2023-10-03 |
Estimated Primary Completion Date : | 2024-04 |
Estimated Study Completion Date : | 2024-07 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 50 Years |
Sexes Eligible for Study: | MALE |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
ICON, plc.
Lenexa, Kansas, United States, 66219
RECRUITING
ICON Early Phase Services, LLC
Saint Anthony, Texas, United States, 78209
RECRUITING
ICON
Salt Lake City, Utah, United States, 84124