A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 12
- 主要终点
- Number of Participants With Treatment-related Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
详细描述
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
- •Investigator Global Assessments (IGA) score of 2 or 3
- •Body Mass Index (BMI) = 18 - 35 kg/m^2
- •Negative Pregnancy test for females
排除标准
- •Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
- •Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
- •Major surgery within 3 months of Screening
- •Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
- •Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
研究组 & 干预措施
VTP-38543 0.05%
VTP-38543 0.05% administered topically every 12 hours for 28 days.
干预措施: VTP-38543 (Drug)
VTP-38543 0.15%
VTP-38543 0.15% administered topically every 12 hours for 28 days.
干预措施: VTP-38543 (Drug)
Vehicle without Transcutol®P
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
干预措施: Vehicle without Transcutol®P (Other)
VTP-38543 1%
VTP-38543 1% administered topically every 12 hours for 28 days.
干预措施: VTP-38543 (Drug)
Vehicle with Transcutol®P
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
干预措施: Vehicle with Transcutol®P (Other)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events (AEs)
时间窗: Baseline (Day 0) to Day 35
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
时间窗: Baseline (Day 0) to Day 35
Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline (Day 0) to Day 35
Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
时间窗: Baseline (Day 0) to Day 35
A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
次要结局
- Maximum Plasma Concentration (Cmax) for VTP-38543-001(Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose))
- Time to Maximum Plasma Concentrations (Tmax) for VTP-38543(Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose))
- Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543(Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose))
- Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543(Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose))
- Elimination Half-life (t½) for VTP-38543(Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose))
- Percentage Change From Baseline in Total Body Surface Area (BSA)(Baseline (Day 0) to Day 28)
- Percentage Change From Baseline in Investigator Global Assessments (IGA) Score(Baseline (Day 0) to Day 28)
- Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score(Baseline (Day 0) to Day 28)
- Percentage Change From Baseline Eczema Area and Severity Index (EASI)(Baseline (Day 0) to Day 28)
- Percentage Change From Baseline in Pruritus VAS Score(Baseline (Day 0) to Day 28)
- Percentage Change From Baseline in VAS Sleep Score(Baseline (Day 0) to Day 28)