drugset / Trial / NCT07085520

A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches

NCT07085520

Non-randomizedParallel-groupDouble-blindOther

Summary

The goal of this clinical trial is to evaluate the skin safety of a soluble denosumab microneedle patch in participants with osteoporosis and osteoarthritis. The main questions it aims to answer are: * Is the soluble denosumab microneedle patch safe for use on the skin? * What are the potential skin reactions to the patch? Researchers will compare different doses of the microneedle patch to assess its safety. Participants will: * Apply the microneedle patch to four different areas around their knee * Undergo skin assessments at various time points after application * Be monitored for any adverse skin reactions The study will take place at a single center and involve a small number of participants to provide preliminary data on the safety of this novel drug delivery system.

Timeline

Start
2025-07-31
Primary completion
2025-10-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 0.24 mg Topical
Subject Denosumab Monoclonal antibody 1.2 mg Topical
Subject Denosumab Monoclonal antibody 6 mg Topical