Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Study Overview
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Brief Summary
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Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).

Official Title
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A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Conditions
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Moderate to Severe Glabellar Lines

Intervention / Treatment
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* Biological: ATGC-100
* Biological: Botox®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females aged between 19 to 65 years old Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown Subjects who voluntarily signed the informed consent Exclusion Criteria: Subjects with general neuromuscular synaptic disorders Presence or history of eyelid and/or ptosis Subjects with noticeable facial asymmetry Inability to substantially lessen glabellar frown lines even by physically spreading apart Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics Subjects who are taking Anti-Coagulant and Anti-Platelet agent Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug Subjects with skin disorders at the injection site Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment Any other planned facial aesthetic procedure in the glabellar area during the trial period Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period A history of drug or alcohol abuse Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATGC-100 (Phase I/II)<br>ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) | Biological: ATGC-100<br>* Clostridium Botulinum Type A<br>|
| Active Comparator: Botox® (Phase II)<br>Botox® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) | Biological: Botox®<br>* Clostridium Botulinum Type A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) |  | Up tp 12 weeks | 
| Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) |  | 4 weeks after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II) |  | 8, 12 weeks after the injection | 
| Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II) |  | 4, 8, 12 weeks after the injection | 
| Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II) |  | 4, 8, 12 weeks after the injection | 
| Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II) |  | Up tp 12 weeks |