drugset
drugset / Trial / NCT05743634

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

NCT05743634 ↗

Phase 1/2 Completed 140 enrolled Chongqing Claruvis Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-03-22
Primary completion
2023-02-13
Completion
2023-02-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 0.25 ml Intramuscular
Subject YY001 Protein / enzyme biologic 0.25 ml Intramuscular

Indications

No indication recorded.