A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Immunogenicity of LY3832479 Given as a Single Intravenous Dose in Healthy Participants
概览
- 阶段
- 1 期
- 干预措施
- LY3832479
- 疾病 / 适应症
- Healthy
- 发起方
- Eli Lilly and Company
- 入组人数
- 26
- 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
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.
研究者
入排标准
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history and physical examination
排除标准
- •Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- •Pregnant women and women of childbearing potential
- •Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk while taking the investigational product, or of interfering with the interpretation of data
- •Have participated in a clinical study involving an investigational product, with last dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing
研究组 & 干预措施
LY3832479
Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.
干预措施: LY3832479
Placebo
Participants received single IV dose of Placebo.
干预措施: Placebo
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
时间窗: Baseline through Follow-up (Week 12)
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
次要结局
- PK: Maximum Serum Concentration (Cmax) of LY3832479(Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479(Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85)