A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 0.24 mg | Topical |
| Subject | Denosumab | Monoclonal antibody | 1.2 mg | Topical |
| Subject | Denosumab | Monoclonal antibody | 6 mg | Topical |