A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").
The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.
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
- •Have venous access sufficient to allow for blood sampling and administration of investigational product
排除标准
- •Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females)
- •Must not show evidence of active or latent tuberculosis (TB)
- •Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening or intend to receive during the study
- •Must not be immunocompromised
- •Must not have known hypersensitivity to hyaluronidases
- •Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- •Must not have significant allergies to humanized monoclonal antibodies
- •Must not have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
- •Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Must not have had breast cancer within the past 10 years
研究组 & 干预措施
Part A: Placebo
Placebo administered subcutaneously (SC)
干预措施: Placebo (Drug)
Part A: LY3074828
LY3074828 administered SC
干预措施: LY3074828 (Drug)
Part B: Placebo
Placebo administered SC
干预措施: Placebo (Drug)
Part B: LY3074828
LY3074828 administered SC
干预措施: LY3074828 (Drug)
Part B: LY900021
LY900021 (LY3074828 + LY9999QS) administered SC
干预措施: LY900021 (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score
时间窗: 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).
次要结局
未报告次要终点