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An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.

Submental Fat Clinical Trial

Official title:
An Open Label Phase 2 Study to Compare the Pharmacokinetics, Efficacy and Safety of RZL-012 in Chinese Subjects Seeking Submental Fat Reduction vs. Non-Chinese Subjects Seeking Submental Fat Reduction

Clinical Trial Summary

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.

Clinical Trial Description

• 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05466448
Study type Interventional
Source Raziel Therapeutics Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 29, 2022
Completion date June 15, 2023
View Details
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