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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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06199336
Enrollment
190
Registered
2024-01-10
Start date
2024-01-19
Completion date
2024-09-09
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Glabellar Lines

Keywords

Recombinant Botulinum Toxin Type A, Glabellar Lines

Brief 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.

Interventions

BIOLOGICALJHM03

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

BIOLOGICALBOTOX®

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

BIOLOGICALPlacebo

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

Sponsors

JHM BioPharma (Tonghua) Co. , Ltd.
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blinded

Intervention model description

Placebo and active controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 criteria

1. Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study. 2. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc. 3. 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). 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 prior to study treatment. 6. History of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frameDescription
Phase1Within 28 daysThe incidence rate of adverse events and severe adverse events within 28 days after injection;
Phase2within 4 weeksPercentage 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026