None listed
Conditions
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.
Interventions
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. Fo
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.
Sponsors
Lipidio Pharmaceuticals Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed