NCT05908721已完成2 期
A Multicenter, Single Arm Phase II Clinical Study Evaluating the Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月23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
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.
详细描述
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-
- •Understand the study and sign the Informed Consent Form voluntarily.
- •Take effective contraception measures throughout the study period.
排除标准
- •Used other investigational drugs.
- •Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM
- •Plan to participate in other studies during this clinical trial.
- •With malignant or benign tumors of the nasal cavity.
- •Other reasons the researcher believes that the subject is not suitable to participate in this study.
研究组 & 干预措施
CM310
Experimental
Subcutaneous injection
干预措施: CM310 (Biological)
结局指标
主要结局
Incidence of adverse events
时间窗: Week 12
Incidence (including number of patients, events and percentage) of adverse events.
次要结局
未报告次要终点
研究者
研究点 (1)
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