NCT06918587

Open Label Randomized Comparative Crossover Pharmacokinetic and Immunogenicity Study

Open Label Randomized Two Treatment Two Sequence Two Period Crossover Single Dose Pharmacokinetic Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Prefilled Syringe With on Body Injector 6mg as Test Product (T) Manufactured by Kashiv Biosiciences LLC, USA With Fylnetra Prefilled Syringe 6mg as Reference Product (R) Manufactured by Kashiv Biosciences LLC, USA Administered Through Subcutaneous Route in Normal Healthy Adult (Males and Females ) Human Subjects Under Fasting Condition

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects. Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment. Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DEVICE	TPI-120 with On body injector	6mg Subcutaneous injection
DRUG	Fylntera	6mg subcutaneous

Timeline

• Start date: 2024-09-05
• Primary completion: 2025-02-02
• Completion: 2025-04-01
• First posted: 2025-04-09
• Last updated: 2025-04-09

Locations

1 site across 1 country: Jordan

Regulatory

• FDA-regulated drug study