A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
研究概览
简要总结
The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- •Females who are not of child-bearing potential
- •Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- •Have participated or are currently enrolled in clinical trials with LY3375880
- •Have infections or evidence of infections
- •Are pregnant, lactating or breast feeding
研究组 & 干预措施
Part B: LY3375880 Test 3
LY3375880 Test 3 Formulation administered SC.
干预措施: Manual Syringe (Device)
Part B: LY3375880 Test 3
LY3375880 Test 3 Formulation administered SC.
干预措施: LY3375880 (Drug)
Part A: LY3375880 Formulation A
LY3375880 Formulation A administered subcutaneously (SC).
干预措施: LY3375880 (Drug)
Part A: LY3375880 Formulation A
LY3375880 Formulation A administered subcutaneously (SC).
干预措施: Autoinjector (AI) (Device)
Part A: LY3375880 Formulation B
LY3375880 Formulation B administered subcutaneously SC.
干预措施: LY3375880 (Drug)
Part A: LY3375880 Formulation B
LY3375880 Formulation B administered subcutaneously SC.
干预措施: Autoinjector (AI) (Device)
Part A: LY3375880 Formulation C
LY3375880 Formulation C administered SC.
干预措施: LY3375880 (Drug)
Part A: LY3375880 Formulation C
LY3375880 Formulation C administered SC.
干预措施: Autoinjector (AI) (Device)
Part A: Positive Control
Positive Control (buffer matrix, only) administered SC.
干预措施: Buffer Matrix (No LY3375880) (Drug)
Part A: Positive Control
Positive Control (buffer matrix, only) administered SC.
干预措施: Autoinjector (AI) (Device)
Part B: LY3375880 Test 1
LY3375880 Test 1 Formulation administered SC.
干预措施: LY3375880 (Drug)
Part B: LY3375880 Test 1
LY3375880 Test 1 Formulation administered SC.
干预措施: Manual Syringe (Device)
Part B: LY3375880 Test 2
LY3375880 Test 2 Formulation administered SC.
干预措施: LY3375880 (Drug)
Part B: LY3375880 Test 2
LY3375880 Test 2 Formulation administered SC.
干预措施: Manual Syringe (Device)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
时间窗: Part B: Predose through Day 85
PK: AUC of LY3375880
Visual Analog Scale (VAS) Pain Score
时间窗: Part A: Within 1-minute post injection
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
时间窗: Part B: Predose through Day 85
PK: Cmax of LY3375880
次要结局
未报告次要终点