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

NCT07072611 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-07-20

No results posted yet for this study

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.

Conditions

  • Cutaneous Lupus Erythematosus

Interventions

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

Sponsors & Collaborators

  • Noxopharm Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2026-02-28
Completion
2026-03-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072611 on ClinicalTrials.gov