drugset / Trial / NCT06199336

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

Phase 1/2 Completed 190 enrolled JHM BioPharma (Tonghua) Co. , Ltd.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-01-19
Primary completion
2024-09-09
Completion
2024-09-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 0.5 ml Intramuscular
Subject JHM03 Protein / enzyme biologic 0.5 ml Intramuscular

Indications

No indication recorded.