NCT06126042

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Test Product	DRL\_AB, Pre Filled Syringe; Solution for injection
DRUG	Reference product	USA licenced ORENCIA®, Pre Filled Syringe; Solution for injection
DRUG	Reference Medicinal Product	EU approved ORENCIA®, Pre Filled Syringe; Solution for injection

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-04-01
• Completion: 2024-07-01
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study