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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04283474




Registration number
NCT04283474
Ethics application status
Date submitted
12/02/2020
Date registered
25/02/2020
Date last updated
19/03/2020

Titles & IDs
Public title
Phase 1 XG005-03 Topical Study
Scientific 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
Secondary ID [1] 0 0
PR-XG005-03-PK-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XG005-03
Treatment: Drugs - Placebo

Experimental: XG005-03 - XG005-03 in 3 dose levels

Placebo Comparator: Placebo - Placebo in all cohort


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

Treatment: Drugs: Placebo
Placebo topical formulation

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic Analyses - peak concentration (Cmax)
Timepoint [1] 0 0
Day 1 to 4 days after last dose
Primary outcome [2] 0 0
Pharmacokinetic Analyses - time to peak concentration (Tmax)
Timepoint [2] 0 0
Day 1 to 4 days after last dose
Primary outcome [3] 0 0
Pharmacokinetic Analyses - terminal elimination rate constant (Kel)
Timepoint [3] 0 0
Day 1 to 4 days after last dose
Primary outcome [4] 0 0
Pharmacokinetic of XG005-03 in 1%, 5%, and 10% concentrations - half-life (t½)
Timepoint [4] 0 0
Day 1 to 4 days after last dose
Primary outcome [5] 0 0
Pharmacokinetic Analyses - area under the concentration-time curve from time 0 to the last measurable concentration timepoint (AUC0-t)
Timepoint [5] 0 0
Day 1 to 4 days after last dose
Primary outcome [6] 0 0
Pharmacokinetic Analyses - area under the concentration-time curve, extrapolated to infinity (AUC0-8)
Timepoint [6] 0 0
Day 1 to 4 days after last dose
Secondary outcome [1] 0 0
Safety Analyses - Adverse Event
Timepoint [1] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [2] 0 0
Safety Analyses - ECG-heart rate
Timepoint [2] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [3] 0 0
Safety Analyses - ECG-PR
Timepoint [3] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [4] 0 0
Safety Analyses - ECG-QRS
Timepoint [4] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [5] 0 0
Safety Analyses - ECG-QT
Timepoint [5] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [6] 0 0
Safety Analyses - ECG-QTc
Timepoint [6] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [7] 0 0
Safety Analyses - Skin Assessment Grading-Burger and Bowman scale
Timepoint [7] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [8] 0 0
Safety Analyses - Vital Sign-Systolic Blood Pressure
Timepoint [8] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [9] 0 0
Safety Analyses - Vital Sign-Diastolic Blood Pressure
Timepoint [9] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [10] 0 0
Safety Analyses - Vital Sign-Pulse Rate
Timepoint [10] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [11] 0 0
Safety Analyses - Vital Sign-Tympanic Temperature
Timepoint [11] 0 0
treatment to follow up period, a average 20 days
Secondary outcome [12] 0 0
Safety Analyses - Vital Sign-Respiratory Rate
Timepoint [12] 0 0
treatment to follow up period, a average 20 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xgene Pharmaceutical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04283474
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Feng Xu, PHD
Address 0 0
Xgene Pharmaceutical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherine Mudge
Address 0 0
Country 0 0
Phone 0 0
+61 431 739 345
Fax 0 0
Email 0 0
Katherine.Mudge@cmax.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04283474