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Trial registered on ANZCTR


Registration number
ACTRN12621000255886
Ethics application status
Approved
Date submitted
12/01/2021
Date registered
10/03/2021
Date last updated
13/10/2021
Date data sharing statement initially provided
10/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of a Topical Gel in Healthy Volunteers
Scientific title
A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Healthy Volunteers
Secondary ID [1] 303086 0
GDD3898-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic fatty liver disease 320170 0
Condition category
Condition code
Metabolic and Endocrine 318113 318113 0 0
Other metabolic disorders
Oral and Gastrointestinal 318722 318722 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single centre, double-blind, randomised, vehicle-controlled study to assess the safety, tolerability, and pharmacokinetics of GDD3898 Topical Gel 1.75% following twice daily application (approximately 12 hours apart) for 14 days in healthy volunteers.

The study will be enrolled in 2 cohorts:
Cohort 1 will comprise of 8 subjects randomised to GDD3898 or vehicle gel. The study drug will be applied to the subject's anterior and posterior sections of one forearm (540 cm2) for 14 days. Following the application, subjects will be instructed to avoid contact with the application site for at least 1 hour after application. Serial blood pharmacokinetic samples will be collected. A follow-up telephone contact will be completed 7 days after the last application of the study drug.

A review of safety and PK data for Cohort 1 will be conducted before Cohort 2 is enrolled.

Cohort 2 will comprise of 8 subjects randomised to GDD3898 or vehicle gel. The study drug will be applied to the subject's anterior and posterior sections of one forearm and upper arm (1260 cm2) for 14 days. Following the application, subjects will be instructed to avoid contact with the application site for at least 1 hour after application. Serial blood pharmacokinetic samples will be collected. A follow-up telephone contact will be completed 7 days after the last application of the study drug.

Intervention code [1] 319387 0
Treatment: Drugs
Comparator / control treatment
Active: GDD3898 Topical Gel 1.75%

Control: Vehicle Topical Gel containing only excipients of the active gel and 0% GDD3898
Control group
Placebo

Outcomes
Primary outcome [1] 326098 0
To assess the safety of GDD3898 Topical Gel in healthy volunteers. Safety assessments include vital signs, physical examination, safety laboratory testing, ECG, and opthalmological assessments.

Ophthalmological assessments include visual acuity, eyelid examination, corneal staining, tear break-up time, and dry eye assessment.
Timepoint [1] 326098 0
Vitals signs will be collected at screening and daily from Admission (Day -1) to Discharge (Day 16)

Physical examinations will be collected at Screening, Admission, and Discharge.

Blood samples for safety laboratory testing will be collected at Screening, Admission, Day 14, and Discharge.

ECGs and ophthalmological assessments will be collected at Screening, Admission, and Discharge.
Primary outcome [2] 326664 0
To assess the tolerability of GDD3898 Topical Gel in healthy volunteers by local skin tolerability assessments by assessing the application site for local skin irritation.
Timepoint [2] 326664 0
The application site will be assessed for local skin irritation on Days 1, 7, and 14.
Secondary outcome [1] 390122 0
To evaluate the pharmacokinetic (PK) profile of GDD3898 Topical Gel and its major metabolite GDD3990. PK analysis will be performed for Cmax, AUClast, AUCinf, tmax, t½, AUC0-t, AUC0-24, and AUC.
Timepoint [1] 390122 0
Blood samples for PK analysis will be collected at:
Day 1, 7, and 14: Predose, 1, 2, 4, 6, 8, and 12 hours after the morning application
Day 2, 7, 15: 12 hrs after previous evening's application

Eligibility
Key inclusion criteria
Subjects are required to meet the following criteria in order to be included in the study:
1. Male or female 18-65 years of age
2. BMI between 18.5 and 30 inclusive at screening
3. Women of childbearing potential are required to use a protocol-approved highly effective contraceptive method for at least 4 weeks prior to Day 1 until at least 4 weeks after the last application.
4. Males with female partners of childbearing potential must use reliable forms of contraception form screening to 30 days after the end of treatment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with the following characteristics will be excluded from the study:
1. Females who are breastfeeding, pregnant, or planning to become pregnant
2. History of skin disease or presence of skin condition and prior skin treatment on the arms such as laser hair removal that, in the opinion of the Investigator, would interfere with the study assessments.
3. Presence of scars, birthmarks, tattoos, or excessive hair at the application site(s) that would impede the assessment of local tolerability assessments
4. History of or positive results for hepatitis B, hepatitis C, HIV
5. History of cancer or lymphoproliferative disease within 5 years prior to Day 1
6. Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
7. History of clinically significant drug or alcohol abuse in the year prior to Screening, or positive urine drug or alcohol breath test
8. Current use of nicotine-containing products within 3 months of first application of study drug, or positive urine cotinine test
9. Blood donation within 60 days prior to dosing or plasma donation within 14 days of dosing
10. Worn contact lens within 10 days prior to screening and prior to the first dose of study drug throughout the period of dose application and until the last PK blood draw is collected
11. Corneal or eyelid surgery, such as eyelid repair, reconstruction, and/or lifts, corneal transplantation, LASIK, photorefractive keratectomy, and/or radial keratotomy surgery and/or has a history or presence of dry eye
12. Pyrexia, cough, malaise or any other symptoms or signs consistent with SARS- CoV2 viral infection at any time within 14 days prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computerised randomisation list will be created by an unblinded statistician or designee. Subjects will be randomised to receive GDD3898 Topical Gel or vehicle in a ratio of 3 to 1 respectively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation scheme and codes will be generated by an unblinded statistician and provided to the site prior to study commencement.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
The analysis of safety data will be conducted on the Safety set which will include all subjects who have received at least one application of study drug.

The PK population will consist of all subjects who have received at least one application of study drug and have at least one analysable sample for plasma concentration of GDD3898 and/or GDD3990.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
8/03/2021
Date of last data collection
Anticipated
28/03/2021
Actual
28/03/2021
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18267 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 32336 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 307488 0
Commercial sector/Industry
Name [1] 307488 0
Lipidio Pharmaceuticals Australia Pty Ltd.
Country [1] 307488 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lipidio Pharmaceuticals Australia Pty Ltd.
Address
58 Gipps Street
Collingwood, VIC 3066
Country
Australia
Secondary sponsor category [1] 308168 0
Commercial sector/Industry
Name [1] 308168 0
InClin Pty Ltd
Address [1] 308168 0
210/ 25 Berry Street
North Sydney, NSW 2060
Country [1] 308168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307563 0
Bellberry Human Research Ethics COmmittee
Ethics committee address [1] 307563 0
123 Glen Osmond Road
Eastwood, South Australia, 5063
Ethics committee country [1] 307563 0
Australia
Date submitted for ethics approval [1] 307563 0
Approval date [1] 307563 0
24/12/2020
Ethics approval number [1] 307563 0

Summary
Brief summary
This is a single centre, double-blind, randomised, vehicle-controlled study designed to assess the safety, tolerability, and pharmacokinetics of GDD3898 Topical Gel following twice daily application for 14 days in healthy volunteers.

16 subjects will be enrolled in 2 cohorts.

Cohort 1 will comprise of 8 subjects randomised in a 3: to 1 ratio to be treated with either GDD3898 Topical Gel (1.75%) BID or vehicle gel BID on the anterior and posterior sections one forearm (540 cm2) for 14 days..

Cohort 2 will comprise of 8 subjects randomised in a 3 to :1 ratio to be treated with either GDD3898 Topical Gel (1.75%) BID or vehicle gel BID on the anterior and posterior sections of one arm, both forearm and upper arm (1260 cm2), for 14 days.

Serial blood pharmacokinetic samples will be collected.

After discharge from the CRU on Day 16, all subjects will have a follow-up telephone contact 7 days after last application of study drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107686 0
Dr Thomas Polasek
Address 107686 0
CMAX
18a North Terrace
Adelaide, South Australia, 5000
Country 107686 0
Australia
Phone 107686 0
+61 8 7088 7900
Fax 107686 0
Email 107686 0
[email protected]
Contact person for public queries
Name 107687 0
Taylor Kilfoil
Address 107687 0
InClin Pty. Ltd.
210/ 25 Berry Street
North Sydney, NSW 2060
Country 107687 0
Australia
Phone 107687 0
+61 408 880 403
Fax 107687 0
Email 107687 0
[email protected]
Contact person for scientific queries
Name 107688 0
Taylor Kilfoil
Address 107688 0
InClin Pty. Ltd.
210/ 25 Berry Street
North Sydney, NSW 2060
Country 107688 0
Australia
Phone 107688 0
+61 408 880 403
Fax 107688 0
Email 107688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data to remain confidential


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.