AI-09 In Subjects With Glabellar Lines, GL-101

A Phase 1/2 Study to Establish An Initial Therapeutic Range and Safety Data for AI-09 in the Treatment of Glabellar Lines

AI-09 In Subjects with Glabellar Lines

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: Vehicle; Biological: AI-09

Detailed Description

A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Eirion Research Site
    • Miami, Florida, United States, 33137
      • Eirion Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• able to understand and give written informed consent
• willingness to have their pictures taken
• 20 - 70 years of age
• moderate to severe glabellar lines (IGA 2-3) on contraction
• moderate to severe glabellar lines (SSA 2-3) on contraction
• none to mild glabellar lines wrinkles (IGA 0-1) at rest
• willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
• female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
• female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy)
• subjects should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product

Exclusion Criteria:

• the inability to substantially lessen glabellar lines by physically spreading them apart
• excessive weakness or atrophy in the target muscle(s)
• eyelid ptosis
• presence or history of "dry eye"
• history of periocular surgery, brow lift or related procedures, or deep dermal scarring
• concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
• history of immunization or hypersensitivity to any botulinum toxin serotype
• history of non-response to any prior botulinum toxin treatments
• anticipated need for treatment with botulinum toxin of any serotype for a reason during the trial (other than the investigational treatment)
• any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
• pregnancy or lactation
• application of any topical prescription medication to the treatment area within 14 days prior to treatment
• subjects on clinically significant, concomitant drug therapy
• participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
• alcohol or drug abuse within the past 3 years
• psychiatric disease interfering with the subject's ability to give informed consent
• refusal or inability to comply with the requirements of the protocol for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-09 Dose 1; Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 1; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 2; Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 2; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 3; Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 3; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 4; Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 4; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 5; Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 5; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 6; Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 6; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation
Experimental: AI-09 Dose 7; Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline	Biological: AI-09; Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 7; Vehicle, intramuscular injection, administered once at baseline	Biological: Vehicle; Vehicle Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigators Global Assessment (IGA)	Investigators Global Assessment. Glabellar Line Severity scale where severity is scored between 0-4 (0=absent; 4=severe).	18 Weeks (26 Weeks for Cohorts 4, 5 & 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score	Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments.	Week 1, 2, 4, 8, 12, 18 (Week 26 assessments for Cohorts 4, 5 & 6)

Collaborators and Investigators

• Sponsor: Eirion Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AI-09-GL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No