A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 20
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
- •Have active AD according to study specific criteria
- •Be willing and able to undergo skin biopsies
排除标准
- •Have received certain topical medications for AD within 14 days prior to baseline
- •Have received certain systemic medications for AD within 4 weeks prior to baseline
- •Have received LY3471851 previously
研究组 & 干预措施
12 µg/kg LY3471851
Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
干预措施: LY3471851 (Drug)
10 µg/kg LY3471851
Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks.
干预措施: LY3471851 (Drug)
24 µg/kg LY3471851
Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
干预措施: LY3471851 (Drug)
Placebo
Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Study Completion (up to Week 48)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Trough Concentrations (Ctrough) of LY3471851(Week 12)
- PK: Maximum Concentration (Cmax) of LY3471851(Postdose on Day 1 through Day 14)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851(Postdose on Day 1 through Day 14)