Health TrialsbyHealthPanel

Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

ConditionsLipomaSubmental Fullness
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Ronkyla Plus

    Drug

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

  • Placebo

    Drug

    Normal saline for injection.

  • Kybella

    Drug

    10 mg/mL deoxycholic acid injection

Treatment groups

56 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part I: Dose Level 1Experimental treatment 2 interventions
Group B: Part I: Dose Level 2Experimental treatment 2 interventions
Group C: Part I: Dose Level 3Experimental treatment 2 interventions
Group D: Part I: Dose Level 4Experimental treatment 2 interventions
Group E: Part II: Ronkyla Plus treatmentExperimental treatment 1 intervention
Group F: Part II: Kybella treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part I: Incidence of all adverse events

Also a Part II Secondary Outcome Measure

Time frame
7 months (Part I); 1 month (Part II)
2

Part I: Incidence of all serious adverse events

Also a Part II Secondary Outcome Measure

Time frame
7 months (Part I); 1 month (Part II)
3

Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 bone marrow toxicities

Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

Time frame
7 months (Part I); 1 month (Part II)
4

Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 cardiac toxicities

Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)

Time frame
7 months (Part I); 1 month (Part II)

Secondary outcomes

1

Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of Cycle 2 (Part I only)

At screening, 1 target superficial lipoma will be selected for treatment. Lipoma will be measured in ≥ 2 dimensions (longest length, perpendicular width, and height if possible) using both digital calipers and ultrasound imaging. Almost complete clearance is defined as ≥ 90% reduction in surface area of the target superficial lipoma

Time frame
2 months
2

Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort

Time frame
7 months (Part I); 1 month (Part II)
3

Percentage of subjects with "complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort

Time frame
7 months (Part I); 1 month (Part II)
4

Percentage of subjects with "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort

Time frame
7 months (Part I); 1 month (Part II)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glonova Pharma Co., Ltd

Lead sponsor

T-TOP Clinical Research Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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