Phase 1 XG005-03 Topical Study

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: XG005-03; Drug: Placebo

• Registration Number: NCT04283474
• Lead Sponsor: Xgene Pharmaceutical Group

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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-25
• Study Start: 2020-02-28
• Primary Completion: 2021-01-28
• Study Completion: 2021-01-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
XG005-03	XG005-03	XG005-03 in 3 dose levels
Placebo	Placebo	Placebo in all cohort

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Analyses	Day 1 to 4 days after last dose	area under the concentration-time curve, extrapolated to infinity (AUC0-∞)
Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations	Day 1 to 4 days after last dose	half-life (t½)

Secondary Outcome Measures

Name	Time	Method
Safety Analyses	treatment to follow up period, a average 20 days	Vital Sign-Respiratory Rate

Trial Locations

Locations (1)

CMAX Clinical Research Pty Ltd; 🇦🇺 Adelaide, South Australia, Australia