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A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines

NCT06199336 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-04-02

No results posted yet for this study

Summary

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.

Conditions

  • Moderate to Severe Glabellar Lines

Interventions

BIOLOGICAL

JHM03

Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site.

BIOLOGICAL

BOTOX®

Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.

BIOLOGICAL

Placebo

Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.

Sponsors & Collaborators

  • JHM BioPharma (Tonghua) Co. , Ltd.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2024-09-09
Completion
2024-09-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06199336 on ClinicalTrials.gov