Clinical trial

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

NCT06199336

Name

JHM03-CT101

Description

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.

Trial arms

Trial start

2024-01-19

Estimated PCD

2024-10-25

Trial end

2025-01-24

Status

Recruiting

Phase

Early phase I

Treatment

JHM03

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

Arms:

Treatment Group

BOTOX®

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

Arms:

Active-Controlled Group

Placebo

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

Arms:

Placebo-Controlled Group

Size

178

Primary endpoint

Phase1

Within 28 days

Phase2

within 4 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo and active controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double-blinded', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 178, 'type': 'ESTIMATED'}}

Updated at

2024-04-09

1 organization

2 products

1 drug

1 indication

Organization

JHM BioPharma (Tonghua)

Product

Indication

Product

Drug