Relative Bioavailability of LY3074828 Solution Formulation in Pre-Filled Syringes Compared to Lyophilized Formulation After Single Subcutaneous Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828
研究概览
简要总结
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/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 during the study
- •Must not have been treated with steroids within 1 month of screening, or intend to during the study
- •Must not be immunocompromised
- •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 Day 1
- •Must not have significant allergies to humanised monoclonal antibodies
- •Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever 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
Test 2: 500 mg LY3074828
500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes
干预措施: LY3074828 (Biological)
Test 1: 250 mg LY3074828
250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes
干预措施: LY3074828 (Biological)
Reference: 250 mg LY3074828
250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections
干预措施: LY3074828 (Biological)
结局指标
主要结局
Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828
时间窗: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC\[0-tlast\]) of LY3074828 was evaluated. Unit of measure expansion: microgram\*day per milliliter per milligram (µg\*day/mL/mg).
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828
时间窗: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC\[0-∞\]) of LY3074828 was evaluated.
次要结局
- Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)(Predose Day 1 Through Day 85)