CompletedPhase 1/2

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

China190 participantsStarted 2024-01-19

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Phase1

Timeframe: Within 28 days

Phase2

Timeframe: within 4 weeks

Trial details

NCT IDNCT06199336

SponsorJHM BioPharma (Tonghua) Co. , Ltd.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-09-09

View on ClinicalTrials.gov More Moderate to Severe Glabellar Lines trials