NCT07416955

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

An Open Label, Randomized, Two-treatment, Two Sequence, Two Period, Crossover, Single Dose, Comparative Pharmacokinetic, Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Pre-Filled Syringe With Auto- Injector 6 mg/0.6 mL (T) and Fylnetra Pre-filled Syringe 6 mg/0.6 mL (R) Administered Through Subcutaneous Route, in Normal, Healthy, Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Kashiv BioSciences, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is an open label, randomized, two treatment, two sequence, two period, single dose crossover clinical trial designed to compare the pharmacokinetics, immunogenicity, and safety of Pegfilgrastim TPI 120 (Test) administered via pre filled syringe with auto injector and Fylnetra (Reference) administered via pre filled syringe. The study will be conducted in healthy adult human subjects under fasting conditions. The study aims to enroll a sufficient number of participants to ensure that 180 healthy subjects complete dosing across both periods. Considering the required procedures and a washout period of at least 34 days between the dosing days of Period I and Period II, the total clinical study duration is approximately 51 days from the first check in. Subjects will be randomized into two treatment sequences and will receive a single subcutaneous dose of either the Test or Reference product in each study period. The primary objective is to assess the pharmacokinetic (PK) comparability of the two Pegfilgrastim formulations by evaluating PK parameters including Cmax, AUCt, AUCi, Tmax, Kel, AUC%Extrap\_obs, and tHalf. PK parameters will be calculated using Phoenix® WinNonlin® (Version 8.1.1 or higher) or SAS® (Version 9.4 or higher). Secondary objectives include assessment of safety and tolerability, as well as immunogenicity through anti drug antibody (ADA) evaluations. Comprehensive safety assessments will be performed throughout the study. A complete physical examination will be conducted at screening and at the end of the study or early termination, while abbreviated physical examinations will occur during admission of each period, on Day 15 of Period I, and prior to discharge in each period. Clinical laboratory evaluations will include hematology, including absolute neutrophil count (ANC), coagulation (PT/INR), clinical chemistry, and urinalysis, performed at defined time points: screening, check in of Period 1, two days prior to Period 2 check in, Day 15 of Period I, and end of study or early termination. A 12 lead ECG will be performed at screening, on Day 15 of Period I post dose, and at the end of the study or early termination. Safety screening also includes urine drug screens for drugs of abuse (amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methadone, and phencyclidine) and alcohol breathalyzer testing at screening and prior to admission of each study period. Subjects will be closely monitored for adverse events (AEs), serious adverse events (SAEs), changes in laboratory parameters, vital signs, and any clinically significant abnormalities. Immunogenicity evaluations will be performed at protocol specified time points to assess the presence of ADAs and potential neutralizing antibodies. This study is designed to generate robust comparative PK, safety, and immunogenicity data to support the evaluation of biosimilar comparability between Pegfilgrastim TPI 120 and Fylnetra under fasting conditions in healthy adult subjects.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	TPI-120 Pre-Filled Syringe 6 mg/0.6 mL	TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector - Manufactured/supplied by: Kashiv Biosciences LLC, USA

Timeline

• Start date: 2025-04-05
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study