Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults

The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects and also to assess safety and tolerability of investigational product.

NCT Number	NCT07416955
Lead Sponsor	Kashiv BioSciences, LLC Collaborators: Cliantha Research
Conditions	Healthy Volunteer
Enrollment	180 participants
Start Date	2025-04-05
Primary Completion	2025-10-10 (estimated)
Study Completion	2025-10-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-18