Phase 1 XG005-03 Topical Study

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.

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