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

Phase 1 Completed 180 enrolled Kashiv BioSciences, LLC Cliantha Research · collab

RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start: 2025-04-05
Primary completion: 2025-10-10
Completion: 2025-10-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.