NCT06438757进行中（未招募）2 期
Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma
Jemincare1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年6月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Serum concentrations of JYB1904
研究概览
简要总结
This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent voluntarily;
- •Aged 18-75 years, weight ≥ 40 kg, male or female;
- •Diagnosed Allergic asthma.
排除标准
- •Prior exposure to anti-IgE therapy within 1 year;
- •Allergic to anti-IgE biologics;
- •Current smokers, or quit smoking within 1 year;
- •Combined with other non-allergic diseases that cause IgE elevation；
- •History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome;
- •Other conditions unsuitable for the trial judged by the investigator.
研究组 & 干预措施
JYB1904: Dose-1
Experimental
干预措施: JYB1904 (Drug)
JYB1904: Dose-2
Experimental
干预措施: JYB1904 (Drug)
JYB1904: Dose-3
Experimental
干预措施: JYB1904 (Drug)
Omalizumab
Active Comparator
干预措施: Omalizumab (Drug)
结局指标
主要结局
Serum concentrations of JYB1904
时间窗: Baseline through 337 days post-dose
Serum concentrations of JYB1904, assessed by pre-specified methods
Serum concentrations of IgE
时间窗: Baseline through 337 days post-dose
Serum concentrations of IgE, assessed by pre-specified methods
Adverse Events(AEs)
时间窗: Baseline through 337 days post-dose
Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis
次要结局
- Times of protocol-defined asthma exacerbations during the 24-week treatment period(Baseline through 168 days post-dose)
- Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks(Baseline through 24 weeks post-dose)
- Serum concentrations of anti-drug antibody (ADA)(Baseline through 337 days post-dose)
研究者
研究点 (1)
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