Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Status:
RECRUITING
Trial end date:
2027-01-14
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.