Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
Public ClinicalTrials.gov record NCT07416955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Study identification
- NCT ID
- NCT07416955
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Kashiv BioSciences, LLC
- Industry
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2025
- Primary completion
- Oct 9, 2025
- Completion
- Oct 9, 2025
- Last update posted
- Feb 17, 2026
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cliantha Research | St. Petersburg | Florida | 33714 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07416955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2026 · Synced Jun 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07416955 live on ClinicalTrials.gov.