Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

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.

Eligibility

Inclusion Criteria:

1. Healthy male or female adults aged 18 to 65 years, inclusive.
2. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:

   * 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.
   * Located on the trunk, arms, legs, or neck
   * Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma.

   OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)
3. Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).
4. History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.
5. The health status is assessed by the investigator as "normal healthy" based on required screening assessments.
6. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of contraception from enrollment up to the study end, such as:

   * Intrauterine device
   * Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)
   * Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)
   * Tubal ligation
   * Vasectomized male partner
   * Sexual abstinence

   Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.
7. Able and willing to comply with scheduled clinic visits and clinical trial procedures.
8. Capable of understanding and giving signed informed consent form after full discussion of the research nature of the treatment and its risk and benefits with the investigator/ designee of the sponsor.

Exclusion Criteria:

1. History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).
2. Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).
3. History of diabetes.
4. Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)
5. 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 (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day washout period):

   * Prothrombin time \> 20 seconds.
   * Activated partial thromboplastin time \> 60 seconds.
   * INR \> 3.
6. Any ongoing medical condition with significant risk of bleeding
7. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV/HBV/HCV, or clinically significant laboratory findings that would, in the investigator's judgment, make the subject inappropriate for the study.
8. Administration of an investigational drug within 30 days prior to enrollment.
9. Administration of a COVID-19 vaccine within 30 days prior to enrollment.
10. Abnormal hepatic and renal functions; hematologic changes at screening:

    * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 X upper limit of normal (ULN).
    * Total bilirubin \> 1.5 X ULN.
    * Serum creatinine \> 1.5 X ULN.
    * Hemoglobin \< lower limit of normal (LLN).
    * Platelets ≤ 100.000/mm³.
11. Current malignancy of any organ system or a history within 5 years.
12. Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.

Part I \& Part II Ronkyla Plus cohort specific exclusion criteria:

1. History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.
2. Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.
3. Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).
4. The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology).

Part I dose level 2 and 4 cohorts \& Part II specific exclusion criteria:

1. History of alcohol or drug abuse within the past year prior to Day 1.
2. History of smoking or use of nicotine-containing product within 6 months prior to Day 1.
3. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.

Conditions3

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