A Phase 1b Multi-Center, Double-Blind, Randomized Vehicle-Controlled Study Assessing the PK , Pharmacodynamics, Safety and Tolerability of SB414 in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- Plasma concentrations of hMAP3
研究概览
简要总结
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
详细描述
This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 years of age and older, and in good general health;
- •EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
- •Two target lesions at least 5 cm2 with a TLSS ≥
- •Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
- •Willing to not use any other products for AD during the study;
- •Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.
排除标准
- •Concurrent or recent use of topical or systemic medications without a sufficient washout period;
- •Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
- •Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
- •Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
研究组 & 干预措施
SB414 2%
SB414 2% topically twice daily
干预措施: SB414 2% (Drug)
SB414 6%
SB414 6% topically twice daily
干预措施: SB414 6% (Drug)
Vehicle Cream
Vehicle Cream topically twice daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Plasma concentrations of hMAP3
时间窗: Day 15
Peak plasma concentrations of hMAP3 after topical application of SB414
次要结局
- Pharmacodynamics of SB414(Day 15)
- Safety Profile (Reported Adverse Events)(Day 15)
- Efficacy as assessed by EASI (Eczema area and severity index) score(Screening, Baseline and Week 2)
- Investigator Assessment of Tolerability(Baseline, Week 1 and Week 2)
- Efficacy as assessed by Itch NRS(Baseline, Week 1 and Week 2)
- Subject Assessment of Tolerability(Baseline, Week 1 and Week 2)
- Efficacy as assessed by Target Lesion Severity Score(Screening, Baseline, Week 1 and Week 2)