A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3819253 Administered Subcutaneously to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
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 just under the skin to healthy participants. 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 up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history and physical examination
- •Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected
- •Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (<)35 kilograms per square meter (kg/m²)
- •Male participants must agree to adhere to contraception restrictions
- •Female participants must be of non-childbearing potential
排除标准
- •Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of
- •Significantly altering the absorption, metabolism, or elimination of drugs
- •Constituting a risk while taking the investigational product, or
- •Interfering with the interpretation of data
- •Have significant allergies to humanized monoclonal antibodies (mAbs)
- •Have any of the following that are clinically significant:
- •Multiple or severe drug allergies, or
- •Intolerance to topical corticosteroids, or
- •Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- •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
- •Have had breast cancer within the past 10 years
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus [HCV] ribonucleic acid [RNA])
研究组 & 干预措施
LY3819253
Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.
干预措施: LY3819253 (Drug)
Placebo
Participants received a single SC dose of Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
时间窗: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose
PK: AUC\[0-∞\] of LY3819253
次要结局
未报告次要终点