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

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Kashiv BioSciences, LLC
Study ID
NCT07416955
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Apr 5, 2025
Status verified
Feb 2026
Primary completion
Oct 10, 2025
Completion
Oct 10, 2025

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector
    Intervention Group
  • Active Comparator: Fylnetra Pre-Filled Syringe 6 mg/0.6 mL
    Comparator Group

Primary Outcome Measure

Pharmacokinetic parameter [ Time Frame: Baseline to Day 15 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cliantha ResearchSt. PetersburgFlorida33714-

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By research site
Cliantha Research· St. Petersburg, FL

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