A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Dose of NKTR-358 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 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 evaluate the safety and tolerability of a study drug known as LY3471851 in healthy participants. The study will last about 50 days for each participant.
详细描述
LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males and females, as determined by medical history and physical examination
- •Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)
排除标准
- •Previous or current autoimmune disease/disorder
- •Current active bacterial, viral, or fungal infection
- •Administration of an inactivated vaccine within two weeks of study drug administration or live attenuated vaccine within 90 days of dosing .
研究组 & 干预措施
LY3471851
Healthy participants in each cohort will receive single subcutaneous (SC) doses of LY3471851.
干预措施: LY3471851 (Drug)
Placebo
Healthy participants in each cohort will receive the placebo comparator.
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 up to Day 50
Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851(Predose on Day 1 through Day 50)
- Pharmacodynamics (PD): Mean Change from Baseline in Regulatory T cells (Tregs)(Predose on Day 1 through Day 50)
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3471851(Predose on Day 1 through Day 50)
- PD: Change from Baseline in Treg Activation Markers(Predose on Day 1 through Day 50)