A Comparative Evaluation of Pharmacokinetics and Immunogenicity.

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.

NCT Number	NCT06918587
Lead Sponsor	Kashiv BioSciences, LLC
Conditions	Febrile Neutropenia
Enrollment	180 participants
Start Date	2024-09-05
Primary Completion	2025-05-25 (estimated)
Study Completion	2025-05-25 (estimated)
Updated on ClinicalTrials.gov	2026-04-20