deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 2-arm 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

Sponsor: Kashiv BioSciences, LLC

Conditions Febrile Neutropenia
Interventions Fylntera TPI-120 with On body injector
Updated 1 time since 2025 Last updated: Apr 8, 2025 Started: Sep 5, 2024 Primary completion: Feb 2, 2025 Completion: Apr 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06918587, this PHASE1 trial focuses on Febrile Neutropenia and remains ongoing. Sponsored by Kashiv BioSciences, LLC, it has been updated 1 time since 2024, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2025 – present · 15 months · monthly snapshotActive Not Recruiting

Change History

1 version recorded
Active Not Recruiting — PHASE1 [monthly]

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kashiv BioSciences, LLC
Data source: Kashiv BioSciences, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations