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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2024-09-09

Brief Summary

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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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Detailed Description

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Conditions

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Moderate to Severe Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo and active controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Double-blinded

Study Groups

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Treatment Group

Single injection with JHM03 in glabellar lines

Group Type EXPERIMENTAL

JHM03

Intervention Type BIOLOGICAL

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

Active-Controlled Group

Single injection with BOTOX® in glabellar lines

Group Type ACTIVE_COMPARATOR

BOTOX®

Intervention Type BIOLOGICAL

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

Placebo-Controlled Group

Single injection with Placebo in glabellar lines.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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JHM03

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

Intervention Type BIOLOGICAL

BOTOX®

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No