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

Last updated: March 28, 2025
Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.
Overall Status: Completed

Phase

1/2

Condition

N/A

Treatment

BOTOX®

JHM03

Placebo

Clinical Study ID

NCT06199336
JHM03-CT101
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects between 18 and 65 years of age.

  2. Moderate to severe glabellar lines at maximum frown at baseline.

Exclusion

Exclusion Criteria:

  1. Previous use of any botulinum toxin within 6 months prior to screening, or plan touse any botulinum toxin during the study.

  2. Use of medications that affect neuromuscular transmission within 4 weeks prior toscreening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergicdrugs,benzodiazepines,etc.

  3. Suffering from any neurological disorders that increase the risk of exposure tobotulinum toxin type A, including peripheral motor nerve diseases (such asamyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscularjunction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).

  4. Known allergy or hypersensitivity to any component of the study products.

  5. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week priorto study treatment.

  6. History of alcohol or drug abuse.

Study Design

Total Participants: 190
Treatment Group(s): 3
Primary Treatment: BOTOX®
Phase: 1/2
Study Start date:
January 19, 2024
Estimated Completion Date:
September 09, 2024

Connect with a study center

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

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