NCT07617324尚未招募2 期
A Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Pharmacokinetics of Stapokibart Injection in Adolescent Patients With SAR Under Background Therapy
Chengdu Kangnuoxing Biopharma,Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年6月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
This study is a multicenter, single-arm, open-label, phase II study to evaluate the safety, pharmacokinetics, and immunogenicity of Stapokibart injection in Adolescent Patients with SAR.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the Informed Consent Form.
- •Age ≥ 12 years old and <18 years old, weight ≥ 40 kg.
- •With a diagnosis of SAR, with or without allergic conjunctivitis, and the SAR duration was ≥ 2 years.
排除标准
- •Not enough washing-out period for previous therapies.
- •With other poorly controlled serious diseases or chronic conditions.
- •With any conditions that are not suitable for participation in this study by investigators.
研究者
研究点 (1)
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