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

NCT07072611 | Recruiting Early Phase 1 DMC

• 1 other identifier: PHA-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Percentage of Target Toxicities after a single treatment

  Part 1: Percentage of Target Toxicities after a single application of study treatment

  4 days -3 days after last application of topical treatment

• Percentage of Target Toxicities after two-week treatment

  Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment

  17 days - 3 days after last dose of treatment

• Percentage of Adverse events (AEs) after a single treatment

  Part 1: Percentage of AEs after a single application of study treatment

  4 days -3 days after last application of topical treatment

• Percentage of Adverse events (AEs) after two-week treatment

  Part 2: Percentage of AEs following two weeks of daily application of study

  17 days - 3 days after last dose of treatment

• Percentage of Serious Adverse events (SAEs) after a single treatment

  Part 1: Percentage of SAEs after a single application of study treatment

  4 days -3 days after last application of topical treatment

• Percentage of serious Adverse events (SAEs) after two-week treatment

  Part 2: Percentage of SAEs following two weeks of daily application of study treatment.

  17 days - 3 days after last dose of treatment

Secondary Outcomes (13)

• Maximum Tolerated Dose (MTD) of a single application of SOF-SKN

  4 days -3 days after last application of topical treatment

• Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN

  17 days - 3 days after last dose of treatment

• Maximum concentration (Cmax) of a single application of SOF-SKN

  7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)

• Time to reach Cmax (tmax) of a single application of SOF-SKN

  7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)

• Area Under the Concentration-Time Curve (AUC) of a single application of SOF-SKN

  7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)

Study Arms (8)

Cohort 1

ACTIVE COMPARATOR

Single application of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 0.25%; Drug: Placebo

Cohort 2

ACTIVE COMPARATOR

Single application of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 0.5%; Drug: Placebo

Cohort 3

ACTIVE COMPARATOR

Single application of 2 g SOF-SKN cream 10 mg/g (1% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 1%; Drug: Placebo

Cohort 4

ACTIVE COMPARATOR

Single application of 2 g SOF-SKN cream 20 mg/g (2% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 2%; Drug: Placebo

Cohort 5

ACTIVE COMPARATOR

Multiple applications of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 0.25%; Drug: Placebo

Cohort 6

ACTIVE COMPARATOR

Multiple applications of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 0.5%; Drug: Placebo

Cohort 7

ACTIVE COMPARATOR

Multiple applications of 2 g SOF-SKN cream 10 mg/g (1% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 1%; Drug: Placebo

Cohort 8

ACTIVE COMPARATOR

Multiple applications of 2 g SOF-SKN cream 20 mg/g (2% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back.

Drug: SOF-SKN 2%; Drug: Placebo

Interventions

SOF-SKN 0.25% DRUG

cream for topical application

Cohort 1; Cohort 5

SOF-SKN 0.5% DRUG

cream for topical application

Cohort 2; Cohort 6

SOF-SKN 1% DRUG

cream for topical application

Cohort 3; Cohort 7

SOF-SKN 2% DRUG

cream for topical application

Cohort 4; Cohort 8

Placebo DRUG

cream for topical application

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteers 18 to 64 years.
• Participants with Fitzpatrick skin type I to IV.
• Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.
• No Allergies.
• Contraception.
• Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.

You may not qualify if:

• Allergic constitution.
• Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.
• Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.
• Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.
• Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and/or suntan/burn that could interfere with the test field evaluation.
• Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and/or scabs) present in the target area on the back that could interfere with the test field evaluation.
• Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.
• Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.

Sponsors & Collaborators

• Noxopharm Limited: lead

Study Sites (1)

Doherty Clinical Trials

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Gisela Mautner, MD-PhD

CONTACT

+ 61 2 9144 2223; medical.information@noxopharm.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 18, 2025
• Study Start: July 14, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-06

Locations

AU (1)