A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single and Multiple Ascending Doses of FRTX-02 in Healthy Subjects and Subjects With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- The number of participants with treatment-emergent adverse events.
研究概览
简要总结
FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor.
详细描述
This is a randomized, placebo controlled, double blind study in healthy subjects and subjects with atopic dermatitis that is designed to assess the safety and tolerability of FRTX-02 capsules at single and multiple ascending doses.
Safety will be assessed through vital signs, ECG, adverse events and safety laboratory tests.
Pharmacokinetic and pharmacodynamic information will also be collected.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1A Single Ascending Dose (SAD) - Active
Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.
干预措施: FRTX-02 Capsule (Drug)
Part 1A Single Ascending Dose (SAD) - Placebo
Matching placebo will be administered to healthy volunteers.
干预措施: Placebo (Drug)
Part 1B Multiple Ascending Dose (MAD) - Active
Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.
干预措施: FRTX-02 Capsule (Drug)
Part 1B Multiple Ascending Dose (MAD) - Placebo
Matching placebo will be administered to healthy volunteers.
干预措施: Placebo (Drug)
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active
FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis.
干预措施: FRTX-02 Capsule (Drug)
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo
Matching placebo will be administered daily for 28 days to healthy volunteers.
干预措施: Placebo (Drug)
结局指标
主要结局
The number of participants with treatment-emergent adverse events.
时间窗: Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)
Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results.
次要结局
未报告次要终点