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

Официальное название

A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат SOF-SKN 0.25%
  cream for topical application
• Препарат SOF-SKN 0.5%
  cream for topical application
• Препарат SOF-SKN 1%
  cream for topical application
• Препарат SOF-SKN 2%
  cream for topical application
• Препарат Placebo
  cream for topical application

Первичные конечные точки

• Percentage of Target Toxicities after a single treatment [Срок оценки: 4 days -3 days after last application of topical treatment]
• Percentage of Target Toxicities after two-week treatment [Срок оценки: 17 days - 3 days after last dose of treatment]
• Percentage of Adverse events (AEs) after a single treatment [Срок оценки: 4 days -3 days after last application of topical treatment]
• Percentage of Adverse events (AEs) after two-week treatment [Срок оценки: 17 days - 3 days after last dose of treatment]
• Percentage of Serious Adverse events (SAEs) after a single treatment [Срок оценки: 4 days -3 days after last application of topical treatment]
• Percentage of serious Adverse events (SAEs) after two-week treatment [Срок оценки: 17 days - 3 days after last dose of treatment]

Вторичные конечные точки (12)

• Maximum Tolerated Dose (MTD) of a single application of SOF-SKN [Срок оценки: 4 days -3 days after last application of topical treatment]
• Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN [Срок оценки: 17 days - 3 days after last dose of treatment]
• Maximum concentration (Cmax) of a single application of SOF-SKN [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)]
• Time to reach Cmax (tmax) for multiple applications of SOF-SKN [Срок оценки: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)]
• Area Under the Concentration-Time Curve (AUC) for multiple applications of SOF-SKN [Срок оценки: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)]
• AUC Extrapolated to Infinity (AUC0-inf) for multiple applications of SOF-SKN [Срок оценки: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)]
• Half-life (t1/2) for multiple applications of SOF-SKN [Срок оценки: 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Doherty Clinical Trials — Melbourne

Идентификаторы

NCT: NCT07072611 · PHA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗