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RECRUITING
NCT07237425
PHASE1

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

Sponsor: Glonova Pharma Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Safety, Efficacy and Pharmacokinetic Evaluation Study of Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-11-14

Completion Date

2027-01-14

Last Updated

2025-12-04

Healthy Volunteers

Yes

Interventions

DRUG

Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

DRUG

Placebo

Normal saline for injection.

DRUG

Kybella

10 mg/mL deoxycholic acid injection

Locations (2)

Cathay General Hospital

Taipei, Da'an District, Taiwan

Cathay General Hospital Sijhih Branch

New Taipei City, Sijhih District, Taiwan