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 | Completed Phase 1 DMC

• 1 other identifier: JHM03-CT101
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Glabellar Lines

Keywords

Recombinant Botulinum Toxin Type A, Glabellar Lines

Outcome Measures

Primary Outcomes (2)

• Phase1

  The incidence rate of adverse events and severe adverse events within 28 days after injection;

  Within 28 days

• 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

Study Arms (3)

Treatment Group

EXPERIMENTAL

Single injection with JHM03 in glabellar lines

Biological: JHM03

Active-Controlled Group

ACTIVE COMPARATOR

Single injection with BOTOX® in glabellar lines

Biological: BOTOX®

Placebo-Controlled Group

PLACEBO COMPARATOR

Single injection with Placebo in glabellar lines.

Biological: Placebo

Interventions

JHM03 BIOLOGICAL

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

Treatment Group

BOTOX® BIOLOGICAL

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

Active-Controlled Group

Placebo BIOLOGICAL

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

Placebo-Controlled Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age.
• Moderate to severe glabellar lines at maximum frown at baseline.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JHM BioPharma (Tonghua) Co. , Ltd.: lead

Study Sites (1)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Placebo and active controlled

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: January 19, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: April 2, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)