A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 1-mL Autoinjector in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration
研究概览
简要总结
The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.
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
- •Must be healthy males or females
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 8 weeks 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 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
125 mg LY3074828 Prefilled Syringe (PFS)
Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm.
Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
干预措施: LY3074828 (Drug)
125 mg LY3074828 Prefilled Syringe (PFS)
Reference 1: Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL pre-filled syringe (PFS) administered in the arm.
Reference 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
Reference 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
干预措施: Pre-filled syringe (PFS) (Device)
125 mg LY3074828 Autoinjector (AI)
Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm.
Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
干预措施: LY3074828 (Drug)
125 mg LY3074828 Autoinjector (AI)
Test 1: Participants received 125 mg LY3074828 solution formulation SC via 1-mL Autoinjector (AI) administered in the arm.
Test 2: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
Test 3: Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
干预措施: Autoinjector (AI) (Device)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration
时间窗: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration
Visual Analog Scale (VAS) Pain Score by Device
时间窗: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
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 horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
时间窗: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828
时间窗: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
时间窗: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
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 horizontal 100 mm scale from 0 mm (no pain) to 100 mm (severe pain).
次要结局
未报告次要终点