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

NCT05743634 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-02-24

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 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

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.

Sponsors & Collaborators

  • Chongqing Claruvis Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qingfeng Li · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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 NCT05743634 on ClinicalTrials.gov