drugset / Trial / NCT06937944

Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

NCT06937944

Phase 3 Recruiting 669 enrolled JHM BioPharma (Tonghua) Co. , Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.

Timeline

Start
2025-04-30
Primary completion
2025-12
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 20 iu
Subject Eveotox Protein / enzyme biologic 20 iu Other

Indications

No indication recorded.