NCT07072611

Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Noxopharm Limited · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2. Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.

Detailed description

The study will contain four, single ascending dose-escalation cohorts and four multiple dose-escalation cohorts allowing an exploration of different doses of SOF-SKN with safety monitoring to ensure the safety of the participants. A maximum of thirty-two (32) participants will be enrolled overall, with a maximum of sixteen (16) participants enrolled into each part of the study. There is to be a 28-day Screening period (Day -28 to -1) for both Part 1 and 2 of the study. Both SAD and MAD will include four treatment cohorts (0.25%, 0.5%, 1% and 2%) of SOF-SKN. Participants enrolled Part 1 (SAD) will receive a single dose of 2 g Soft-SKN cream while the participants enrolled in Part 2 (MAD) will receive daily applications of 2 g SOF-SKN cream for 14 days.

Conditions

• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	SOF-SKN 0.25%	cream for topical application
DRUG	SOF-SKN 0.5%	cream for topical application
DRUG	SOF-SKN 1%	cream for topical application
DRUG	SOF-SKN 2%	cream for topical application
DRUG	Placebo	cream for topical application

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-07-18
• Last updated: 2025-07-20

Locations

1 site across 1 country: Australia