A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 11
- 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 purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization
- •Are men or non-pregnant women
- •Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study
- •Agree to the collection of nasopharyngeal swabs and venous blood
排除标准
- •Require mechanical ventilation or anticipated impending need for mechanical ventilation
- •Received convalescent COVID-19 plasma treatment prior to enrollment
- •Were resident in a nursing home or long-term care facility immediately prior to current hospitalization
- •Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
- •Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air at rest at randomization.
研究组 & 干预措施
LY3819253
Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
干预措施: LY3819253 (Drug)
Placebo
Participants received single dose of Placebo as intravenous infusion.
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 Day 60
An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29(Day 29)
- Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC(Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose)
- Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load(Baseline, Day 29)
- Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance(Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose)