Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGlonova Pharma Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Healthy male or female adults aged 18 to 65 years, inclusive.
History of slow growth followed by dormancy, and stable for at least 6 months.
Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.
Discrete, oval to rounded in shape, not hard or attached to underlying tissue.
Disqualifiers
History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).
Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).
History of diabetes.
Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)
Trial design
Treatments tested in this trial
- Ronkyla Plus
- Placebo
- Kybella
Treatment groups
56 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Glonova Pharma Co., Ltd
Lead sponsor
T-TOP Clinical Research Co., Ltd.
Collaborator
Source ClinicalTrials.gov