NCT05476679

Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events

An Open Label Phase 2 Study to Evaluate the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Raziel Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, open-label, 2-stage, adaptive-design study in which subjects will be randomized into one of 5 treatment groups comprised of RZL-012 with or without additional study treatments:

Detailed description

In the first stage of the study, 5 subjects will be randomized into each of the treatment groups. Study outcomes will be assessed up to one week thereafter to determine the need to modify additional study treatments. Subsequently up to 10 additional subjects will be randomized into each of the treatment groups for the second stage of the study. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a single treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days. Each subject will be treated with the same dose of RZL-012 : • 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, Each subject will receive additional study treatments in accordance with the treatment group to which the subject is randomized.

Conditions

• Submental Fat

Interventions

Type	Name	Description
DRUG	RZL-012	50mg/ml drug formulation
DRUG	RZL-012+Lidacaine injection prior treatment	5ml lidocaine will be injected 10 minutes before RZL-012 treatment
DRUG	RZL-012+Medrol	oral Medrol dose pack (8 mg (2 tablets) on Day 1 before treatment followed by 16 mg after treatment (as per Instructions for Use)). From Day 2, a daily tapering off by 4 mg until Day 6 will be administered per Rx Instructions for use
DRUG	RZL-012+Celecoxib+Zyrtec	200 mg Celecoxib BID and 10 mg Zyrtec BID on Days 1, 2, 3, 4, 5 and 6
DRUG	RZL-012+facial and neck wrap	Universal Facial Band

Timeline

• Start date: 2022-09-25
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2022-07-27
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study