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

NCT05565950 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AI-09-GL-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

AI-09 In Subjects with Glabellar Lines

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1

  Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).

  4 Weeks

Secondary Outcomes (1)

• % of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).

  4 Weeks

Study Arms (14)

AI-09 Dose 1

EXPERIMENTAL

Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 1

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 2

EXPERIMENTAL

Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 2

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 3

EXPERIMENTAL

Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 3

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 4

EXPERIMENTAL

Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 4

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 5

EXPERIMENTAL

Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 5

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 6

EXPERIMENTAL

Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 6

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 7

EXPERIMENTAL

Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 7

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

Interventions

AI-09 BIOLOGICAL

Injectable Botulinum Toxin Type A

AI-09 Dose 1; AI-09 Dose 2; AI-09 Dose 3; AI-09 Dose 4; AI-09 Dose 5; AI-09 Dose 6; AI-09 Dose 7

Vehicle BIOLOGICAL

Vehicle Formulation

Vehicle Dose 1; Vehicle Dose 2; Vehicle Dose 3; Vehicle Dose 4; Vehicle Dose 5; Vehicle Dose 6; Vehicle Dose 7

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to understand and give written informed consent
• willingness to have their pictures taken
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eirion Therapeutics Inc.: lead

Study Sites (4)

Eirion Research Site

Boca Raton, Florida, 33432, United States

Location

Eirion Research Site

Miami, Florida, 33137, United States

Location

Eirion Research Site

New Brighton, Minnesota, 55112, United States

Location

Eirion Research Site

Plano, Texas, 75093, United States

Location

Results Point of Contact

• Title: Sr. VP R & D and Regulatory Operations
• Organization: Eirion Therapeutics

mike@eirionthera.com

2158721131

Study Officials

• Michael Eppolito

  Eirion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: October 3, 2022
• Primary Completion: January 5, 2024
• Study Completion: May 22, 2024
• Last Updated: August 31, 2026
• Results First Posted: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)