A Phase I, Open-Label, Sequential, Single-Dose Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of IVL3001, a Finasteride-Based Novel Long-Acting Injection for Androgenetic Alopecia

The study evaluated the safety, pharmacokinetics, pharmacodynamics, and tolerability of IVL3001, a long-acting injectable formulation of finasteride, in 40 healthy adult males with androgenetic alopecia. Participants received a single subcutaneous injection of 12–36 mg IVL3001 and 1 mg finasteride daily for 28 days. Results showed that IVL3001 was well tolerated, maintained consistent plasma concentrations, and effectively reduced dihydrotestosterone levels. The findings suggest that IVL3001 offers advantages over conventional oral finasteride, including rapid onset, sustained drug concentration, and improved compliance.