NCT06713499已完成1 期
A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年12月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
- •At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;
- •Have atopic dermatitis at screening.
排除标准
- •Before enrollment, the subjects weighed < 15kg;
- •Females who are pregnant or lactating and have a positive pregnancy test result;
- •Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
- •Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
- •Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
- •Has malignancy or has a history of malignancy;
- •Hypersensitivity to the study drug or any ingredient in the study drug.
研究组 & 干预措施
SHR-1819 injection
Experimental
Dose 1, dose 2 and dose 3.
干预措施: SHR-1819 injection (Drug)
结局指标
主要结局
Adverse events
时间窗: Up to 14 weeks.
PR interval
时间窗: Up to 14 weeks.
Heart rate
时间窗: Up to 14 weeks.
QT interval
时间窗: Up to 14 weeks.
QRS duration
时间窗: Up to 14 weeks.
次要结局
- The concentration of SHR-1819 in serum(From the beginning of administration to the 14th week.)
- Changes in the level of TARC/CCL17 in the serum(From the beginning of administration to the 14th week.)
- Evaluate the incidence and timing of ADA positivity for SHR-1819(From the beginning of administration to the 14th week.)
研究者
研究点 (2)
Loading locations...
相似试验
Enrolling By Invitation
2 期
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing CancersAdvanced Solid TumorsNCT05349409Suzhou Suncadia Biopharmaceuticals Co., Ltd.212
招募中
1 期
Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05765032Suzhou Suncadia Biopharmaceuticals Co., Ltd.120
进行中（未招募）
1 期
A Clinical Study of the Safety and Tolerability of SHR-1901 in Subjects With Advanced Malignant TumorsAdvanced Malignant TumorsNCT05193721Suzhou Suncadia Biopharmaceuticals Co., Ltd.25
招募中
1 期
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.HER2-expressing Advanced Solid TumorsNCT06015048Jiangsu HengRui Medicine Co., Ltd.364
尚未招募
2 期
Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLCNSCLCNCT06465238Henan Cancer Hospital30