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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: XG005-03; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xgene Pharmaceutical Pty Ltd
• Investigators: Study Chair: Feng Xu, PHD, Xgene Pharmaceutical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PR-XG005-03-PK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No