A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of subjects with drug related adverse events (AEs)
研究概览
简要总结
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.
详细描述
This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- •Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
- •Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
- •Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
- •History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- •Pregnant or Breasting feeding subject. Women with a positive pregnancy test .
- •Further exclusions criteria apply.
研究组 & 干预措施
HB0034 dose group 1
8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
干预措施: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo (Drug)
HB0034 dose group 2
8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
干预措施: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo (Drug)
HB0034 dose group 3
8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
干预措施: Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo (Drug)
结局指标
主要结局
Percentage of subjects with drug related adverse events (AEs)
时间窗: up to 2000 hours
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
次要结局
- AUC0-infinity(up to 2000 hours)
- Cmax(up to 2000 hours)