Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma

Part I is a randomized, double-blind, placebo-controlled, and sequential dose-escalation study. Eligible subjects will receive intralesional injections of Ronkyla Plus or placebo at a volume dependent on the size of their superficial lipoma, up to a maximum of 10 mL per treatment, at 28-day intervals for up to a maximum of 6 treatments. In the first treatment cycle, subjects will stay in hospital for 3 hours after treatment for evaluation of acute safety profile. Subjects will return to the hospital on Day 8 and Day 29 of each treatment cycle for safety profile evaluation.

Part II is an open-label, single-dose, 2-treatment, parallel study to evaluate the relative bioavailability of Ronkyla Plus injection in comparison with that of Kybella injection. Eligible, non-smoking males and females aged 18 to 65 with treatable superficial lipoma or submental fullness will be included in the study. Twenty (20) subjects for each target symptom, in a total of 40 subjects, are planned to be enrolled in the study to achieve at least 16 evaluable subjects in each treatment group. After screening, subjects will be assigned to Ronkyla Plus or Kybella treatment based on their symptoms and undergo a 16-day PK assessment.

For Ronkyla Plus injection, subject will receive a single intralesional treatment at the maximum tolerated dose (MTD) as determined in Part I. For Kybella injection, subject will receive the maximum dose approved for a single treatment (100 mg) in the submental area.

In the PK assessment period, subjects will visit the hospital in the mornings of Day 3 (48.0 h), Day 5 (96.0 h), Day 8 (168.0 h), Day 11 (240.0 h), and Day 15 (336.0 h), and two consecutive 24-hr PK blood samplings from Day -2 evening to Day 2 morning (pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0 h post-dose on Day 1\~Day 2; same blood sampling time on Day -1\~Day 1 without dosing). Two weeks after the end of the 16-day PK assessment period, subjects of Ronkyla Plus cohort will be eligible for up to 5 additional treatments of Ronkyla Plus for complete clearance of their target superficial lipomas, whereas subjects of Kybella cohort will be eligible for up to 5 additional treatments of Ronkyla (10.56 mg/mL SDC injection approved in Taiwan for submental fullness treatment, pharmaceutical equivalent of Kybella) for improvement of their submental fullness.