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

Early Phase 1RecruitingNCT07072611

Noxopharm Limited32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cutaneous Lupus Erythematosus

Interventions

SOF-SKN 0.25%DRUG

cream for topical application

SOF-SKN 0.5%DRUG

cream for topical application

SOF-SKN 1%DRUG

cream for topical application

SOF-SKN 2%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Doherty Clinical Trials

Melbourne, Victoria, Australia

RECRUITING

Outcomes

Primary Outcomes

Percentage of Target Toxicities after a single treatment

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 17 days - 3 days after last dose of treatment

Secondary Outcomes

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

To determine the MTD of a single application of SOF-SKN cream.

Central Contacts

Gisela Mautner, MD-PhD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

cream for topical application

PlaceboDRUG

cream for topical application

Time frame: 4 days -3 days after last application of topical treatment

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

To determine the MTD of multiple applications following two weeks of daily application of study treatment with SOF-SKN cream.

Time frame: 17 days - 3 days after last dose of treatment

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

PK parameters will be calculated to determine the degree of systemic exposure. The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected.

Time frame: 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

PK parameters will be calculated to determine the degree of systemic exposure. Time to reach Cmax (tmax), if possible, as minimal systemic exposure is expected.

Time frame: 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

PK parameters will be calculated to determine the degree of systemic exposure. The Area Under the Concentration-Time Curve (AUC) will be calculated from Time Zero to the Last Measurable Plasma Concentration (AUC0-last), if possible, as minimal systemic exposure is expected.

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

AUC Extrapolated to Infinity (AUC0-inf) of a single application of SOF-SKN

PK parameters will be calculated to determine the degree of systemic exposure. The AUC Extrapolated to Infinity (AUC0-inf) will be calculated, if possible, as minimal systemic exposure is expected.

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

Half-life (t1/2) of a single application of SOF-SKN

PK parameters will be calculated to determine the degree of systemic exposure. The Half-life (t1/2) will be calculated, if possible, as minimal systemic exposure is expected.

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

Maximum concentration (Cmax) for multiple applications of SOF-SKN

PK parameters will be calculated to determine the degree of systemic exposure The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected.