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Twenty-Four (24) subjects (12 for each study cohort ) will be included in the study. Subjects in each cohort will be injected with a different dose of RZL-012. The total of 24 subjects will be enrolled in 3 clinical sites.
This is a single blinded, randomized, placebo-controlled, 2-cohort clinical study in healthy volunteers. Each cohort will be comprised of 8 active (RZL-012) and 4 placebo subjects. All subjects will receive a single dose of RZL-012 or vehicle into the submental area, after which they will be monitored for safety and efficacy during 84 days of follow-up.
All subjects per cohort will be randomized to either active treatment or placebo at a ratio of 2:1 per cohort.
Subjects will be blinded to study treatment while physicians will not be blinded.
The study will be composed of 2 treatment cohorts, 12 subjects each. The study will be conducted in 3 clinical sites. Per each study cohort, a total of 12 subjects will be randomized to receive active or placebo treatment (2:1) according to a randomization program that will be prepared prior to study initiation. Each clinical site will have at least one active and one placebo treatment subject per each study cohorts. In case of slow enrollment in one of the sites, other sites may complete the enrollment of subjects in each cohort.
Cohort 1 (N=12) - Each subject will be dosed with up to 120 mg RZL-012 (depending on submental fat area) or vehicle.
Cohort 2 (N=12) - Each subject will be dosed with up to 240 mg RZL-012 (depending on submental fat area) or vehicle.
Treatment of cohort 2 will start following cohort 1 day 28 data. An independent Data Safety Monitoring Board (DSMB) will review safety and tolerability data for cohort 1 subjects, 28 days after injection, and decide whether it is safe to increase the dose for the next study cohort. The decision to proceed to the cohort 2 will be made within 30 days (28 days + 2 days) after injection of the last dosed subject in cohort 1.
The DSMB will be comprised of two independent MDs with expertise in the aesthetic area and in conduction of clinical trials.
In case of serious safety concerns (e.g. prolonged severe swelling or severe pain following injection) among cohort 1 subjects receiving the 120mg dose, sponsor and DSMB may decide to reduce or stay with the 120mg/subject dose level for cohort 2 subjects.
Not yet recruiting
Raziel Therapeutics Ltd.
Published on BioPortfolio: 2019-09-18T03:27:56-0400
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