A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Adverse Effects
研究概览
简要总结
The purposes of this study are to evaluate the following in healthy participants: 1) LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system reactions to LY2928057.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must either be a healthy male (and willing to use reliable birth control method during the study and for 3 months following last study drug dose), or a healthy female who cannot become pregnant
- •Must have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m^2), inclusive, and a minimum body weight of 55 kg
- •Must have acceptable blood and urine laboratory test results for the study
- •Must have suitable veins suitable for easy blood collection and study drug administration
- •Must be reliable, follow study procedures, and willing to be available for the duration of the study
- •Must have given written informed consent
- •Must have acceptable blood pressure and pulse rate for the study
排除标准
- •Blood test shows that participant has anemia due to lack of iron
- •Currently participating in another clinical study or has completed one less than 30 days ago
- •Allergic to biologic agents
- •Have previously taken part in this study
- •Have abnormal electrocardiogram (ECG) findings that suggest an increased risk with study participation
- •Have a history of significant disease that may affect drug actions or pose risk when taking study medication
- •Have a history of drug or alcohol abuse
- •Are infected with human immunodeficiency virus (HIV)
- •Have hepatitis B
- •Are pregnant or breastfeeding
- •Intend to use over-the-counter or prescription medication within 14 days before dosing, other than oestrogen/progesterone as hormone replacement therapy (HRT). Participants taking these medications are expected to be on chronic, stable doses. Certain medications (for example, vitamin supplements) may be permitted at the discretion of the investigator.
- •Have donated more than 450 milliliter (mL) of blood within the last 3 months
- •Have a regular alcohol intake greater than 21 units per week (male), or 14 units per week (female), or are unwilling to stop alcohol as required for the study (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of spirits)
- •Are a smoker (smoking more than 10 cigarettes per day) or have used equivalent tobacco products. Participants will not be allowed to smoke while in the study unit.
- •Have received live vaccine(s) within 1 month of screening, or intend to during the study
- •Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before receiving study drug in this study
- •Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
- •Have any active mental health illness
- •Study doctor does not feel the participant should be in the study for any reason
研究组 & 干预措施
Placebo
Single intravenous placebo dose.
干预措施: Placebo (Drug)
30 mg LY2928057 (Cohort 1)
Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
干预措施: LY2928057 (Drug)
100 mg LY2928057 (Cohort 2)
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
干预措施: LY2928057 (Drug)
300 mg LY2928057 (Cohort 3)
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
干预措施: LY2928057 (Drug)
1000 mg LY2928057 (Cohort 4)
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
干预措施: LY2928057 (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Adverse Effects
时间窗: Baseline through Day 85
A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.
次要结局
- Pharmacokinetics, Area Under the Curve (AUC)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Maximum Concentration (Cmax)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Change From Baseline in Serum Iron(Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22)
- Number of Participants Forming Antibody to LY2928057(Baseline through Day 85)
- Pharmacokinetics, Time to Maximum Concentration (Tmax)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Systemic Clearance (CL)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Volume of Distribution (V)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Terminal Half-Life (t1/2)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)