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

Noxopharm

Status and phase: Enrolling; Early Phase 1

Conditions: Cutaneous Lupus Erythematosus

Treatments: Drug: SOF-SKN 2%; Drug: SOF-SKN 1%; Drug: SOF-SKN 0.5%; Drug: Placebo; Drug: SOF-SKN 0.25%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07072611

PHA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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32 participants in 8 patient groups

Cohort 1

Active Comparator group

Description:

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.

Treatment:

Drug: SOF-SKN 0.25%

Drug: Placebo

Cohort 2

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 0.5%

Cohort 3

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 1%

Cohort 4

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 2%

Cohort 5

Active Comparator group

Description:

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.

Treatment:

Drug: SOF-SKN 0.25%

Drug: Placebo

Cohort 6

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 0.5%

Cohort 7

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 1%

Cohort 8

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: SOF-SKN 2%