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

Moderate to Severe Glabellar Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199336
• Other study ID #: JHM03-CT101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 19, 2024
• Est. completion date: January 24, 2025

Study information

• Verified date: April 2024
• Source: JHM BioPharma (Tonghua) Co. , Ltd.
• Contact: Danhua Lin
• Phone: 15811460241
• Email: danhua.lin[@]jhm-biopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: January 24, 2025
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Glabellar Lines

Intervention

Biological:
• JHM03
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site.
• BOTOX®
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.
• Placebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site.

Locations

Country	Name	City	State
China	Guangdong Second Provincial General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
JHM BioPharma (Tonghua) Co. , Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase1	The incidence rate of adverse events and severe adverse events within 28 days after injection;	Within 28 days
Primary	Phase2	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.	within 4 weeks