OncoMatch/Clinical Trials/NCT07237425
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Is NCT07237425 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ronkyla Plus and Kybella for lipoma.
Treatment: Ronkyla Plus · Kybella — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: surgical treatment
Lab requirements
Blood counts
hemoglobin ≥ lower limit of normal; platelets > 100,000/mm³; prothrombin time ≤ 20 seconds; activated partial thromboplastin time ≤ 60 seconds; INR ≤ 3
Kidney function
serum creatinine ≤ 1.5 X ULN
Liver function
AST or ALT ≤ 2.5 X ULN; total bilirubin ≤ 1.5 X ULN
Abnormal hepatic and renal functions; hematologic changes at screening: AST or ALT > 2.5 X ULN; total bilirubin > 1.5 X ULN; serum creatinine > 1.5 X ULN; hemoglobin < lower limit of normal (LLN); platelets ≤ 100,000/mm³. A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any clinically significant bleeding disorder.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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