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NCT07416955
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
Phase 1 trial testing TPI-120 Pre-Filled Syringe 6 mg/0.6 mL in Healthy Volunteer in 180 participants. Completed in 10 October 2025.
10 October 2025
Quick facts
| Lead sponsor | Kashiv BioSciences, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 5 April 2025 |
| Primary completion | 10 October 2025 |
| Estimated completion | 10 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL — full drug profile →
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Kashiv BioSciences, LLC — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07416955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kashiv BioSciences, LLC trials
Trials by the same sponsor.
- NCT06929052 — A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects. · Phase 1 · completed
- NCT06929039 — Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity St · Phase 1 · completed
- NCT05774639 — Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathi · Phase 3 · completed
- NCT06074757 — Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study · Phase 1 · completed
- NCT05564611 — PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07416955 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kashiv BioSciences, LLC
- Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07416955.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing