A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Status:
NOT_YET_RECRUITING
Trial end date:
2026-05-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology