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

NCT06126042 Phase 1 UNKNOWN

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.

Details

Lead sponsor	Dr. Reddy's Laboratories Limited
Phase	Phase 1
Status	UNKNOWN
Enrolment	330
Start date	2023-10-03
Completion	2024-07

Conditions

• Rheumatoid Arthritis

Interventions

• Test Product
• Reference product
• Reference Medicinal Product

Primary outcomes

• Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(INF)] will be derived from serum concentration versus time data [Time frame over 85 days as mentioned] — 1hour prior to the drug administration and at hours 1,4,12,24,36,48,60,72,84,96,108,120,132,144,156,168,216, post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71, 85 (End Of Study)
  Pharmacokinetic parameters - AUC (0-∞)
• Single-dose pharmacokinetic parameter Maximum observed serum concentration (Cmax) will be derived from serum concentration versus time data [Time frame over 85 days] — 1hour prior to the drug administration, at hours 1,4,12,24,36,48, 60,72,84,96,108,120,132,144,156,168,216 post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71,85 (End Of Study)
  Pharmacokinetic parameters - Cmax

Countries

United States