Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route

Rheumatoid Arthritis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT06126042
• Study type: Interventional
• Source: Dr. Reddy's Laboratories Limited
• Contact: Vinu Jose, MD DM
• Phone: +91 - 40-4464-4000
• Email: vinujosem@drreddys.com
• Status: Recruiting
• Phase: Phase 1
• Start date: October 3, 2023
• Completion date: July 2024