NCT07321834

A Study to Evaluate AI-09 In Participants With Glabellar Lines

A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Eirion Therapeutics Inc. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.

Detailed description

This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	AI-09 Ready Use Injectable Botulinum Toxin	AI-09 Ready Use Injectable Botulinum Toxin
BIOLOGICAL	Vehicle	Vehicle

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study