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NCT07416955 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
A Phase 1 study, sponsored by Kashiv BioSciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT07416955 is a Phase 1 study that has completed, run by Kashiv BioSciences. The registered enrollment target is 180 participants.
The verdict
NCT07416955, a Phase 1 study, has completed, sponsored by Kashiv BioSciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL TPI-120 Pre-Filled Syringe 6 mg/0.6 mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-04-05 |
| Est. Completion | 2025-10-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07416955
The ClinicalTrials.gov registry entry for NCT07416955 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kashiv BioSciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TPI-120 Pre-Filled Syringe 6 mg/0.6 mL is the first listed.
NCT07416955 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07416955 about?
NCT07416955 is a clinical study titled "Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults". 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 ...
What is the current status of trial NCT07416955?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2025-04-05. Estimated completion is 2025-10-10.
What interventions are being tested in trial NCT07416955?
The interventions under investigation include: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL (BIOLOGICAL).
Who is sponsoring clinical trial NCT07416955?
This trial is sponsored by Kashiv BioSciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
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