Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 4, 2024

Primary Completion Date

October 16, 2024

Study Completion Date

February 25, 2025

Conditions
Rheumatoid Arthritis (RA
Interventions
DRUG

Abatacept

Test Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA.

DRUG

Abatacept

Reference Product (B) (US-licensed ORENCIA): 'ORENCIA' (abatacept) injection 125 mg/mL - Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA.

DRUG

Abatacept

Reference Product (C) (EU-authorized ORENCIA): 'ORENCIA' 125 mg solution for injection (abatacept) - Marketing Authorization Holder: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland.

Trial Locations (1)

Unknown

Not Disclosed, Missisauga

Sponsors
All Listed Sponsors
lead

Kashiv BioSciences, LLC

INDUSTRY

NCT06929039 - Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects | Biotech Hunter | Biotech Hunter