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

Phase 1

Completed

• Conditions: Moderate to Severe Glabellar Lines
• Interventions: Biological: BOTOX®; Biological: Placebo; Biological: JHM03

• Registration Number: NCT06199336
• Lead Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-29
• Study First Submitted QC: 2023-12-29
• Study First Posted: 2024-01-10
• Study Start: 2024-01-19
• Status Verified: 2024-04
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-Controlled Group	BOTOX®	Single injection with BOTOX® in glabellar lines
Placebo-Controlled Group	Placebo	Single injection with Placebo in glabellar lines.
Treatment Group	JHM03	Single injection with JHM03 in glabellar lines

Primary Outcome Measures

Name	Time	Method
Phase2	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.
Phase1	Within 28 days	The incidence rate of adverse events and severe adverse events within 28 days after injection;

Trial Locations

Locations (1)

Guangdong Second Provincial General Hospital; 🇨🇳 Guangzhou, Guangdong, China