Actively Recruiting
A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN Cream in Healthy Participants
Led by Noxopharm Limited · Updated on 2025-07-20
32
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of SOF-SKN cream applied topically in healthy volunteers aged 18 to 64 years. The study is designed in two parts: Part 1 uses a single ascending dose (SAD) approach, and Part 2 uses a multiple ascending dose (MAD) approach. This phase I clinical trial aims to monitor how the body reacts to different concentrations of the cream and to assess pharmacokinetics. The study includes four dose levels (0.25%, 0.5%, 1%, and 2%) applied as 2 g of SOF-SKN cream to a 10 x 30 cm area on either side of the participant's back. Part 1 participants receive a single application, while Part 2 participants apply the cream daily for 14 days. Each participant also receives a placebo cream on the opposite side of the back to serve as a control. Safety monitoring will be conducted throughout the dose escalation. Participants will undergo a 28-day screening before dosing. After treatment, safety assessments will be made by tracking target toxicities, adverse events, and serious adverse events over days following the last application. Pharmacokinetic measurements will be taken at multiple timepoints up to 24 hours after a single dose and up to 17 days for multiple doses. The study will enroll up to 32 participants, with up to 16 in each part, and will follow them closely to monitor safety and how the drug behaves in the body.
CONDITIONS
Brief Title
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 64 years
- Fitzpatrick skin type I to IV
- Back surface area of at least 24 x 30 cm to allow two separate 10 x 30 cm application areas with 4 cm separation
- No allergies
- Willing to use contraception
- Willing to avoid moisturizers and other topical products on the back 24 hours before and during the study
You will not qualify if you...
- Allergic constitution
- Use of antihistamines or topical drugs at the application site within 72 hours before treatment
- Hair removal treatments like laser, shaving, or waxing on the target area within 1 week before screening
- Hypertrichosis on the back or tattoos covering more than 30% of the back
- Presence of inflammatory skin conditions or suntan/burn that may affect evaluation
- Non-inflammatory skin lesions or changes in the target area that could interfere with test evaluation
- History or presence of melanoma or non-melanoma skin cancer within the last 3 years
- Any other skin disease or visible skin conditions that might interfere with test field evaluation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
Duration - 1 day for single application cohorts; 14 days for multiple application cohorts
Participants receive either a single application or daily applications of SOF-SKN cream or placebo applied topically to the back in dose-escalation cohorts.
1 visit for single application cohorts; daily applications for 14 days for multiple application cohorts
Duration - Up to 17 days after last treatment
Participants are monitored for safety and pharmacokinetics after the last application of SOF-SKN cream.
Multiple visits over 4 days for single application cohorts; multiple visits over 17 days for multiple application cohorts
Trial Site Locations
Total: 1 location
1
Doherty Clinical Trials
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
G
Gisela Mautner, MD-PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here