NCT06929039

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

A Randomized , Open Label, Three Arm, Parallel Group, Single Dose, Comparative Pharmacokinetic , Safety, and Immunogenicity Study Comparing KSHB002 (Abatacept) 125 mg/ ml Pre-filled Injection With US-Licenced ORENCIA and EU-Approved ORENCIA Administered Through Subcutaneous Route in Healthy Adult Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if Test Product KSHB002 shows equivalence in terms of PK , safety and immunogenicity as compared to reference product ORENCIA used to treat Rheumatoid arthritis . Participants will: Take drug Test or a reference subcutaneously as a single dose and these participants will be healthy volunteers Primary Endpoint: The following pharmacokinetic parameters will be determined as: Cmax and AUCi, of KSHB002 (Abatacept), US-licensed ORENCIA and EU-authorized ORENCIA. Secondary Endpoint : Safety will be evaluated from occurrence of adverse events post dose. The number, severity and relation to treatment will be collected by the reporting of the adverse events (AE) and monitoring of clinically relevant changes e.g., vital signs, physical examination and lab values in blood and urine. * Immunogenicity will be evaluated from the number/percentage of subjects positive for ADA (Anti-Drug Antibody) and Neutralizing Anti-drug antibody * Secondary pharmacokinetic endpoints will be evaluated as AUCt, Tmax, Kel and tHalf.

Detailed description

A randomized, open label three-arm, parallel group, single dose comparative pharmacokinetic, safety and immunogenicity study comparing KSHB002 (Abatacept) Injection, 125 mg/mL with US-licensed ORENCIA and EU-authorized ORENCIA administered through subcutaneous route in healthy adult human subjects.

Conditions

• Rheumatoid Arthritis (RA

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-04
• Primary completion: 2024-10-16
• Completion: 2025-02-25
• First posted: 2025-04-15
• Last updated: 2026-04-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study