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

Study Overview
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Brief Summary
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AI-09 In Subjects with Glabellar Lines

Detailed Description
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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.

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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: AI-09
* Biological: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |