NCT05743634

A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. · Industry
• 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 YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	YY001	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
BIOLOGICAL	OnabotulinumtoxinA	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
BIOLOGICAL	Placebo	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2023-02-24
• Last updated: 2023-02-24

Locations

6 sites across 1 country: China