Phase 1 XG005-03 Topical Study

Study Overview
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Brief Summary
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Phase 1, randomized, single-blinded, placebo-control, ascending single and multiple dose of the PK, safety, and tolerability of XG005-03 topical formulation in Healthy Volunteers.

Detailed Description
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This is a single-blind, placebo-controlled study which will investigate the PK, safety and tolerability of XG005-03 topical formulation, in three ascending concentrations after single and multiple topical applications in healthy subjects. The trial consists of two parts: a single ascending dose (SAD; Part 1) and a multiple ascending dose (MAD; Part 2). The MAD study will begin after the SAD portion of the study is complete. The study will consist of 4 weeks of screening period, treatment period (1 day of dosing for SAD and 6.5 days for MAD), and 14 days of safety follow-up period. Each subject will serve as his/her own control, as the XG005-03 and placebo will be applied on contralateral legs. Application of XG005-03 or placebo to a particular leg will be randomly assigned. Approximately 36 healthy subjects will be enrolled. Eighteen healthy subjects (3 alternates per dose group) in Part 1 (SAD) and Part 2 (MAD), who fulfill eligibility criteria will receive the study drug: XG005-03 (1%, 5%, and 10%) and placebo.

Official Title
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A Phase 1, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of XG005-03 (Topical) in Healthy Subjects

Conditions
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Pain

Intervention / Treatment
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* Drug: XG005-03
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females between 18 and 55 years of age BMI 18.0 to 30.0 kg/m2 Non-pregnant, non-breastfeeding female subjects Exclusion Criteria: Unstable or severe illness Skin infection or lesion Subjects with scars, moles, tattoos at application site Expose to excessive UV Hypersensitivity or allergy to NSAID

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XG005-03<br>XG005-03 in 3 dose levels | Drug: XG005-03<br>* 3 different concentrations (1%, 5%, 10%) of XG005-03 topical formulation<br>|
| Placebo Comparator: Placebo<br>Placebo in all cohort | Drug: Placebo<br>* Placebo topical formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Analyses | peak concentration (Cmax) | Day 1 to 4 days after last dose | 
| Pharmacokinetic Analyses | time to peak concentration (Tmax) | Day 1 to 4 days after last dose | 
| Pharmacokinetic Analyses | terminal elimination rate constant (Kel) | Day 1 to 4 days after last dose | 
| Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations | half-life (t½) | Day 1 to 4 days after last dose | 
| Pharmacokinetic Analyses | area under the concentration-time curve from time 0 to the last measurable concentration timepoint (AUC0-t) | Day 1 to 4 days after last dose | 
| Pharmacokinetic Analyses | area under the concentration-time curve, extrapolated to infinity (AUC0-∞) | Day 1 to 4 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Analyses | Adverse Event | treatment to follow up period, a average 20 days | 
| Safety Analyses | ECG-heart rate | treatment to follow up period, a average 20 days | 
| Safety Analyses | ECG-PR | treatment to follow up period, a average 20 days | 
| Safety Analyses | ECG-QRS | treatment to follow up period, a average 20 days | 
| Safety Analyses | ECG-QT | treatment to follow up period, a average 20 days | 
| Safety Analyses | ECG-QTc | treatment to follow up period, a average 20 days | 
| Safety Analyses | Skin Assessment Grading-Burger and Bowman scale | treatment to follow up period, a average 20 days | 
| Safety Analyses | Vital Sign-Systolic Blood Pressure | treatment to follow up period, a average 20 days | 
| Safety Analyses | Vital Sign-Diastolic Blood Pressure | treatment to follow up period, a average 20 days | 
| Safety Analyses | Vital Sign-Pulse Rate | treatment to follow up period, a average 20 days | 
| Safety Analyses | Vital Sign-Tympanic Temperature | treatment to follow up period, a average 20 days | 
| Safety Analyses | Vital Sign-Respiratory Rate | treatment to follow up period, a average 20 days |