NCT07295496进行中（未招募）1 期
A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
- •Age ≥18 years of age, male or female;
- •Body mass index (BMI) 18-26 kg/m2 (inclusive) for Part A healthy subjects and BMI 18-40 kg/m2 (inclusive) for Part B acute gout flare subjects; Part B acute gout flare subjects also needed to meet the following criteria
- •Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
- •Other inclusion criteria set by protocol
排除标准
- •Subjects meeting any of the following criteria are not eligible to attend this clinical study:
- •Difficulties in venous blood collection or a history of dizziness when encountering blood or needles;
- •Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
- •Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial;
- •Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
- •Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening;
- •History of malignancy;
- •Female during pregnancy or lactation;
- •Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening;
- •Has a history of neuropsychiatry or any other disease/ailment that is unsuitable for this clinical trial at the discretion of the Investigator;
- •Part B acute gout flare subjects also needed to exclude the following criteria:
- •Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
- •Infection/septic arthritis, or other acute inflammatory arthritis;
- •Other exclusion criteria set by protocol
研究组 & 干预措施
IBI3011
Active Comparator
IBI3011 group
干预措施: IBI3011 (Drug)
Placebo
Placebo Comparator
IBI3011 placebo group
干预措施: IBI3011 Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 12 week
To investigate the safety characteristics.
次要结局
- Immunogenic outcome(12 week)
- AUC(12 Week)
- Cmax(12 Week)
- CL or CL/F(12 Week)
- V or V/F(12 Week)
- t1/2(12 Week)
研究者
研究点 (1)
Loading locations...
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