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

NCT07416955 | Completed Phase 1 FDA Drug

• 1 other identifier: C1C04946
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Pegfilgrastim

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter

  Cmax,

  Baseline to Day 15

• Pharmacokinetic parameter

  AUCt

  Time Frame: Baseline to Day 15

• Pharmacokinetic parameter

  AUC0-inf

  Time Frame: Baseline to Day 15

Study Arms (2)

TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector

EXPERIMENTAL

Intervention Group

Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL

Fylnetra Pre-Filled Syringe 6 mg/0.6 mL

ACTIVE COMPARATOR

Comparator Group

Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL

Interventions

TPI-120 Pre-Filled Syringe 6 mg/0.6 mL BIOLOGICAL

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

Fylnetra Pre-Filled Syringe 6 mg/0.6 mL; TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years of age, both inclusive, at the time of consent.
• Gender: Male and/or non-pregnant, non-lactating female.
• Willing to provide written informed consent to participate in the study.
• Able to communicate effectively with study personnel.
• Subject having weight greater than or equal to 50 kg
• BMI: 19.0 to 30.0 kg/m2, both inclusive
• Non-smoker and non-tobacco/non-nicotine user (i.e., having no past history of smoking and tobacco/nicotine consuming for at least one year prior to screening).
• Alcohol breathalyzer test result must be negative during screening and prior to Period 1 dosing.
• Negative urine drug screen including amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine during screening and prior to Period 1 dosing.
• The subject has a normal ECG (12 leads) as per the investigator judgement, at screening and on admission day (before admission) of period 1.
• Subject complies with injection site evaluation at screening and on admission day (before admission) of period 1.
• The subject result of hemoglobin is within normal range or ± 5% of medical lab reference range at screening

You may not qualify if:

• History of antibodies or allergic responses to pegfilgrastim, filgrastim or other GCSF stimulant medications or other related drugs, or any of its formulation ingredients.
• Any infection, cough or fever or suffered an acute illness within 1 week prior to first study drug administration.
• Subject having hematologic laboratory abnormalities
• The subject has been hospitalized within three months before the study or during the study
• The subject has been participating in any clinical study (e.g., pharmacokinetics, bioavailability and bioequivalence studies) within the last 30 days prior to the present study
• Clinically significant vital sign abnormalities
• Positive hepatitis screen (includes subtypes B \& C) and/or a positive test result for HIV antibody.
• Study participants who have received a known investigational drug within 30 days or within seven elimination half-lives of the administered drug prior to the initial dose of study drug, whichever is greater.
• Study participant who has donated blood and/or had a blood loss of approximately 1 unit or 450 mL within 90 days prior to the initial dosing of the study drug and/or study participant who had blood loss, excluding volume drawn at screening for this study, prior to initial dosing of study drug, whichever is greater
• Study participant who has a condition or is taking or has taken a medication that, in the Investigator's judgment, makes the study participant ineligible or places the study participant at undue risk
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the study participant's participation in this study.
• Unavailable for any confinement days or scheduled visits.

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead
• Cliantha Research: collaborator

Study Sites (1)

Cliantha Research

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Tamatha F Zemzars, MD

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 18, 2026
• Study Start: April 5, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)