This is a Phase 2, open label study that will consist of a screening period, baseline period in which subjects will receive a single treatment session and a follow-up period. The single treatment session will consist of multiple injections of RZL-012 into the submental area under the chin. Blood samples will be collected from all subjects for PK analyses in the first 30 hours after dosing. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.
• RZL-012 (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection point that results in a total dose/volume of 240±30mg mg/4.8±0.6 mL RZL-012 Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal dose of 270 mg RZL-012 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Luxurgery
New York, New York, United States
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
Measurement of maximum drug concentration (Cmax) (ng/mL)
Time frame: 48 hours
Pharmacokinetics Measure - Area Under the Plasma Concentration Versus Time Curve (AUC) (mg*h/L)
Time frame: 48 hours
Efficacy -Change in Score According to Clinician Chin Assessment Tool (C-CAT)
To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Clinician Chin Assessment Tool (C-CAT) by proportion of subjects with reduction in C-CAT score. The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck
Time frame: 84 days
Efficacy - Change in Score According to Subject Chin Assessment Tool (S-CAT)
To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Subject Chin Assessment Tool (S-CAT) by proportion of subjects who has reduction in S-CAT score. The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck
Time frame: 84 days
Efficacy - Change in Submental Fat Thickness
Change from baseline in submental fat thickness (%), as measured with MRI in RZL-012 treated subjects vs. placebo treated subjects on Day 84 following injection
Time frame: 84 days
Safety - Adverse Events Follow up
To evaluate the safety of RZL-012 subcutaneous injections in the submental area in Chinese vs. non Chinese population, as assessed by spontaneous adverse event reports and post injection evaluation of treatment area. Treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus. The number of subjects with treatment-related adverse events will be compared within each treatment group, as assessed by CTCAE v4.0
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Time frame: 84 days