A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.

Phase 1 Completed 150 enrolled Kashiv BioSciences, LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/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.

Timeline

Start: 2025-01-29
Primary completion: 2025-08-15
Completion: 2025-08-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	ADL-018	Unknown	—	Subcutaneous

Indications

No indication recorded.