NCT06199336

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: JHM BioPharma (Tonghua) Co. , Ltd. · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-19
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2024-01-10
• Last updated: 2025-04-02

Locations

1 site across 1 country: China