Phase 1 XG005-03 Topical Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04283474

Enrollment

Registered

2020-02-25

Start date

2020-02-28

Completion date

2021-01-28

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

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.

Interventions

DRUGXG005-03

3 different concentrations (1%, 5%, 10%) of XG005-03 topical formulation

DRUGPlacebo

Placebo topical formulation

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy males or females between 18 and 55 years of age 2. BMI 18.0 to 30.0 kg/m2 3. Non-pregnant, non-breastfeeding female subjects

Exclusion criteria

1. Unstable or severe illness 2. Skin infection or lesion 3. Subjects with scars, moles, tattoos at application site 4. Expose to excessive UV 5. Hypersensitivity or allergy to NSAID

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic Analyses	Day 1 to 4 days after last dose	peak concentration (Cmax)
Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations	Day 1 to 4 days after last dose	half-life (t½)

Secondary

Measure	Time frame	Description
Safety Analyses	treatment to follow up period, a average 20 days	Adverse Event

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026