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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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

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Cutaneous Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind

Study Groups

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Cohort 1

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 0.25%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 2

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 0.5%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 3

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 1%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 4

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 2%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 5

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 0.25%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 6

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 0.5%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 7

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 1%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Cohort 8

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.

Group Type ACTIVE_COMPARATOR

SOF-SKN 2%

Intervention Type DRUG

cream for topical application

Placebo

Intervention Type DRUG

cream for topical application

Interventions

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SOF-SKN 0.25%

cream for topical application

Intervention Type DRUG

SOF-SKN 0.5%

cream for topical application

Intervention Type DRUG

SOF-SKN 1%

cream for topical application

Intervention Type DRUG

SOF-SKN 2%

cream for topical application

Intervention Type DRUG

Placebo

cream for topical application

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes