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

NCT05476679 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-01-30

Study results available
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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:

Conditions

  • Submental Fat

Interventions

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

Sponsors & Collaborators

  • Raziel Therapeutics Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-25
Primary Completion
2023-06-12
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05476679 on ClinicalTrials.gov