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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: Completed Phase 1 study, sponsored by Kashiv BioSciences.
NCT07416955 is a Phase 1 study that has completed, run by Kashiv BioSciences. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax,
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 |
What the finished NCT07416955 record still lists
NCT07416955 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07416955's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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