A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ELA026 Following Intravenous and/or Subcutaneous Administration of Single and Multiple Doses in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].
研究概览
简要总结
ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.
详细描述
This is a multi-center, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, and PD of ELA026 following single and multiple IV and/or SC dose administration in healthy adult volunteers, including a subgroup of Japanese volunteers.
The study will consist of 2 parts:
- Part 1: single ascending doses (SAD) in up to 11 SAD cohorts plus a Japanese cohort
- Part 2: multiple doses (MD) up to 6 MD cohorts
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age.
- •Must be in good general health.
- •No clinically significant abnormal laboratory values during screening.
- •Body mass index of 18 - 32 kg/m2.
排除标准
- •Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening.
- •Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed).
- •Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results.
- •Active or latent tuberculosis (TB), regardless of treatment history,
- •Positive drug abuse test.
- •Positive HIV, HBV, HCV test results.
- •Clinically significant ECG test results.
- •Clinically significant vital sign results.
研究组 & 干预措施
Part 1: Single Ascending Dose
Cohort 1 Single dose: 0.001 mg/kg IV
Cohorts 2 - 11 Single dose: dose level and route (IV or SC) to be determined
Japanese Cohort Single dose: dose level and route (IV or SC) to be determined
干预措施: ELA026 (Drug)
Part 2: Multiple Ascending Dose
Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined
干预措施: ELA026 (Drug)
结局指标
主要结局
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].
时间窗: By week 3
次要结局
- Presence of Anti-drug antibodies to ELA026(By week 3)
- Plasma concentrations of ELA026(By week 3)
- Comparison of ELA026 Maximum observed drug concentration (Cmax)(By week 3)
- Change from baseline of monocytes levels.(By week 3)
- Change from baseline of lymphocytes levels.(By week 3)
- Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC)(By week 3)