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Completed

NCT Number: 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

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.

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Key information

Conditions

Moderate to Severe Glabellar Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects between 18 and 65 years of age.
  • Moderate to severe glabellar lines at maximum frown at baseline.

Exclusion criteria

  • Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
  • Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
  • Suffering from any neurological disorders that increase the risk of exposure to botulinum toxin type A, including peripheral motor nerve diseases (such as amyotrophic lateral sclerosis and motor neuropathy), as well as neuromuscular junction diseases (such as Lambert-Eaton syndrome and myasthenia gravis).
  • Known allergy or hypersensitivity to any component of the study products.
  • Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
  • History of alcohol or drug abuse.

Treatment and study plan

JHM03

Biological

Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site.

BOTOX®

Biological

Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.

Placebo

Biological

Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.

Primary outcomes

  1. Phase1

    Time frame: Within 28 days

    The incidence rate of adverse events and severe adverse events within 28 days after injection;

  2. Phase2

    Time frame: within 4 weeks

    Percentage of Subjects as Responders in the Investigator's live assessment (Using 4-point Photographic Scale) and the subject's self assessment of Glabellar Lines at Maximum Frown.

Sponsors and collaborators

Lead sponsor

JHM BioPharma (Tonghua) Co. , Ltd.

Network

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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