Phase 1 XG005-03 Topical Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283474
• Other study ID #: PR-XG005-03-PK-01
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2020
• Est. completion date: January 28, 2021

Study information

• Verified date: March 2021
• Source: Xgene Pharmaceutical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Australia	CMAX Clinical Research Pty Ltd	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Xgene Pharmaceutical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Analyses	peak concentration (Cmax)	Day 1 to 4 days after last dose
Primary	Pharmacokinetic Analyses	time to peak concentration (Tmax)	Day 1 to 4 days after last dose
Primary	Pharmacokinetic Analyses	terminal elimination rate constant (Kel)	Day 1 to 4 days after last dose
Primary	Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations	half-life (t½)	Day 1 to 4 days after last dose
Primary	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
Primary	Pharmacokinetic Analyses	area under the concentration-time curve, extrapolated to infinity (AUC0-8)	Day 1 to 4 days after last dose
Secondary	Safety Analyses	Adverse Event	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	ECG-heart rate	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	ECG-PR	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	ECG-QRS	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	ECG-QT	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	ECG-QTc	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Skin Assessment Grading-Burger and Bowman scale	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Vital Sign-Systolic Blood Pressure	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Vital Sign-Diastolic Blood Pressure	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Vital Sign-Pulse Rate	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Vital Sign-Tympanic Temperature	treatment to follow up period, a average 20 days
Secondary	Safety Analyses	Vital Sign-Respiratory Rate	treatment to follow up period, a average 20 days