NCT07479576已完成1 期
A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Endpoint
研究概览
简要总结
This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
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 subjects aged from 18 to 45 years (including the boundary value)；
- •BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value);
- •Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment;
- •The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures;
- •Sign the informed consent before joining the study, and fully understand the content, process and possible risks.
排除标准
- •History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients;
- •Alcoholics，or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening;
- •Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；
- •Those who smoked more than 5 cigarettes per day in the 3 months before screening;
- •Drug users in the 5 years prior to screening, or positive urine drug screening；
- •Having used Guselkumab (or its biosimilars) or interleukin (IL-23) targeting agents;
- •Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study;
- •Use of any prescription drug, over-the-counter drug or health product within 14 days prior to screening
- •Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive;
- •Other conditions considered inappropriate to be included in this study.
研究组 & 干预措施
QL2106
Experimental
干预措施: QL2106 (Drug)
Tremfye®
Active Comparator
干预措施: Tremfye® (Drug)
结局指标
主要结局
Pharmacokinetics Endpoint
时间窗: 0-113 days
Peak plasma concentration (Cmax)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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