A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit 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
- 招募中
- 入组人数
- 60
- 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 a single dose or multiple dose.
详细描述
This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 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 exclusion criterias apply.
研究组 & 干预措施
Active Comparator: HB0034 dose group 1
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 2
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 3
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 4
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 5
6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 6
8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Active Comparator: HB0034 dose group 7
8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
干预措施: HB0034 (Drug)
Placebo group
17 subjects receive placebo
干预措施: HB0034 matching placebo (Drug)
结局指标
主要结局
Percentage of subjects with drug related adverse events (AEs)
时间窗: up to 113 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug
次要结局
- Cmax(Up to 113 days)
- AUC0-infinity(up to 113 days)