The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Study Overview
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Brief Summary
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A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines

Official Title
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A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Conditions
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Glabellar Lines

Intervention / Treatment
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* Biological: HU-014 Inj
* Biological: Botox Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely Exclusion Criteria: Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks Subject who has skin disorder including infection and scar on injection site Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc. Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day) Any condition that, in the view of the investigator, would interfere with study participation

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: HU-014 Inj(Phase 1 and 2)<br>HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) | Biological: HU-014 Inj<br>* Clostridium botulinum type A<br>|
| Active Comparator: Botox Inj(Phase 2)<br>Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) | Biological: Botox Inj<br>* Clostridium botulinum type A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) |  | Week 4 | 
| Change from Baseline of Glabellar Lines improvement rate(Frown) |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Columbia Suicide Severity Rating Scale(C-SSRS) |  | Week 4, Week 8, Week 12 | 
| change from Baseline of Glabellar Lines improvement rate (Frown) |  | Week 8, Week 12 | 
| change from Baseline of Glabellar Lines improvement rate (Not frown) |  | Week4, Week 8, Week 12 | 
| Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment |  | Week 4, Week 8, Week 12 | 
| Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product |  | Week 4, Week 8, Week 12 |