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

PHASE1RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

October 3, 2023

Primary Completion Date

April 30, 2024

Study Completion Date

July 31, 2024

Conditions
Rheumatoid Arthritis
Interventions
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

Trial Locations (3)

66219

RECRUITING

ICON, plc., Lenexa

78209

RECRUITING

ICON Early Phase Services, LLC, San Antonio

84124

RECRUITING

ICON, Salt Lake City

All Listed Sponsors
lead

Dr. Reddy's Laboratories Limited

INDUSTRY