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NCT06918587
An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study Under Fasting Conditions.
Phase 1 trial testing TPI-120 with On body injector in Febrile Neutropenia in 180 participants. Completed in 25 May 2025.
25 May 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 September 2024 |
| Primary completion | 25 May 2025 |
| Estimated completion | 25 May 2025 |
| Sites | 1 location across Jordan |
Drugs / interventions tested
- TPI-120 with On body injector
- Fylntera — full drug profile →
Conditions studied
- Febrile Neutropenia — all drugs for Febrile Neutropenia →
Sponsor
Kashiv BioSciences, LLC — full company profile →
Who can join
Adults 18 to 50, any sex, with Febrile Neutropenia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetic Parameter
Time frame: Baseline to Day 15
Cmax -
Pharmacokinetic parameter
Time frame: Baseline to Day 15
AUC0-t -
3. Pharmacokinetic parameter
Time frame: Baseline to Day 15
AUC0-inf
Sponsor's own description
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects. Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment. Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.
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 NCT06918587
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Febrile Neutropenia
Currently open trials in the same condition.
- NCT07204522 — Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients. · recruiting
- NCT05815628 — Next-Generation-Sequencing Approach to Neutropenic Sepsis · recruiting
- NCT06787326 — Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With F · active not recruiting
- NCT05786495 — Short Antibiotic Treatment in High Risk Febrile Neutropenia · NA · recruiting
Other Kashiv BioSciences, LLC trials
Trials by the same sponsor.
- NCT07416955 — Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults · Phase 1 · completed
- 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
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 NCT06918587 (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: 15 April 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/NCT06918587.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing