Status:
COMPLETED
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
Lead Sponsor:
JHM BioPharma (Tonghua) Co. , Ltd.
Conditions:
Moderate to Severe Glabellar Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 sev...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 65 years of age.
- Moderate to severe glabellar lines at maximum frown at baseline.
Exclusion
- Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
- 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).
- Known allergy or hypersensitivity to any component of the study products.
- Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
- History of alcohol or drug abuse.
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2024
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06199336
Start Date
January 19 2024
End Date
September 9 2024
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China