A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of Target Toxicities after a single treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: SOF-SKN 0.25% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 0.5% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 1% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 2% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 0.25% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 0.5% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 1% (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: SOF-SKN 2% (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Target Toxicities after a single treatment
时间窗: 4 days -3 days after last application of topical treatment
Part 1: Percentage of Target Toxicities after a single application of study treatment
Percentage of Target Toxicities after two-week treatment
时间窗: 17 days - 3 days after last dose of treatment
Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment
Percentage of Adverse events (AEs) after a single treatment
时间窗: 4 days -3 days after last application of topical treatment
Part 1: Percentage of AEs after a single application of study treatment
Percentage of Adverse events (AEs) after two-week treatment
时间窗: 17 days - 3 days after last dose of treatment
Part 2: Percentage of AEs following two weeks of daily application of study
Percentage of Serious Adverse events (SAEs) after a single treatment
时间窗: 4 days -3 days after last application of topical treatment
Part 1: Percentage of SAEs after a single application of study treatment
Percentage of serious Adverse events (SAEs) after two-week treatment
时间窗: 17 days - 3 days after last dose of treatment
Part 2: Percentage of SAEs following two weeks of daily application of study treatment.
次要结局
- 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))
- AUC Extrapolated to Infinity (AUC0-inf) of a single application of SOF-SKN(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(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(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(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(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(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(7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17))
- Drug Accumulation Ratio (Rac) for multiple applications of SOF-SKN(7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17))