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

JHM BioPharma (Tonghua) Co. , Ltd.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Moderate to Severe Glabellar Lines

Treatments: Biological: JHM03; Biological: Placebo; Biological: BOTOX®

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06199336

JHM03-CT101

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 3 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Single injection with JHM03 in glabellar lines

Treatment:

Biological: JHM03

Active-Controlled Group

Active Comparator group

Description:

Single injection with BOTOX® in glabellar lines

Treatment:

Biological: BOTOX®

Placebo-Controlled Group

Placebo Comparator group

Description:

Single injection with Placebo in glabellar lines.

Treatment:

Biological: Placebo