NCT04653168已完成1 期
A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With incidence and severity of Injection Site Reaction (ISR)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).
排除标准
- •Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.
- •Have self-perceived dullness or loss of sensation on either side of their abdomen.
- •Have any condition that could affect pain perception from an injection.
- •Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.
研究组 & 干预措施
LY3041658 Low Dose
Experimental
LY3041658 administered by subcutaneous (SC) injection.
干预措施: LY3041658 (Drug)
LY3041658 High Dose
Experimental
LY3041658 administered by SC injection.
干预措施: LY3041658 (Drug)
结局指标
主要结局
Number of Participants With incidence and severity of Injection Site Reaction (ISR)
时间窗: Baseline up to Day 15
Number of Participants With incidence and severity of ISR
Visual Analog Scale (VAS) Score for Injection Site Pain
时间窗: Baseline up to Day 1
VAS Score for Injection Site Pain
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658(Predose up to day 85 postdose)
- PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658(Predose up to day 85 postdose)
研究者
研究点 (1)
Loading locations...
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