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Clinical trial

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

NCT07416955 is registered in ClinicalTrials.gov with Kashiv BioSciences, LLC as lead sponsor.

NCT NCT07416955
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Kashiv BioSciences, LLC
Phase
Phase 1
Overall status
Completed
Start date
April 5, 2025
Completion date
October 10, 2025
Enrollment
180 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteer