A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Participants With Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and 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 tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 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 chronic plaque psoriasis for at least 6 months
- •Be willing and able to undergo skin biopsies
- •Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
- •Female participants must agree to use birth control during the study
排除标准
- •Have had certain types of infection within the last six months
- •Have a clinically significant active infection, or recent acute active infection within the last 30 days
- •Have other serious or unstable illnesses
- •Have a history of organ or bone marrow transplant
- •Have received any live vaccine within the last 4 weeks prior to screening
- •Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
- •Have received topical psoriasis treatment within 14 days prior to study day 1
- •Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1
研究组 & 干预措施
LY3361237
LY3361237 administered subcutaneously (SC).
干预措施: LY3361237 (Drug)
Placebo
Placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 253
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval(Day 1 predose through Day 253)