NCT05779995已完成1 期
Randomized, Double-blind, Placebo-controlled Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of XW001 Inhalation in Children With Respiratory Syncytial Virus (RSV) Infection in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events after receiving XW001
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China
详细描述
In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 1 to 24 months (inclusive) at screening;
- •Weight: 3-20 kg, inclusive;
- •Positive RSV test within 36 hours before randomization;
- •Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;
- •Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.
排除标准
- •Immunocompromised as determined by the investigator;
- •Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;
- •Positive for HBV, HCV or HIV, or patient <6 months old whose mother is positive for HIV;
- •History of seizures or epilepsy, including febrile seizure;
- •Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;
- •History of any surgery within 30 days prior to randomization;
- •Severe dental or facial deformity that will impact on usage of nebulizer;
- •History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening;
- •Known to have received any investigational medicinal products or devices in the past 30 days;
- •Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.
研究组 & 干预措施
C1-Placebo
Placebo Comparator
Matched Placebo once daily
干预措施: Placebo (Drug)
C1-XW001
Experimental
Low dose of XW001 once daily
干预措施: XW001 (Drug)
C2-XW001
Experimental
Medium dose of XW001 once daily
干预措施: XW001 (Drug)
C2-Placebo
Placebo Comparator
Matched Placebo once daily
干预措施: Placebo (Drug)
C3-XW001
Experimental
High dose of XW001 once daily
干预措施: XW001 (Drug)
C3-Placebo
Placebo Comparator
Matched Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events after receiving XW001
时间窗: Day 1 to Day 28
次要结局
- Change from baseline in RSV load via nasopharyngeal swab(Baseline, Day 2 to Day 8)
- Immunogenicity-Anti-drug Antibody of XW001(Baseline, Day 28)
- Change from baseline in Wang Respiratory Score(Baseline, Day 2 to Day 8)
- Pharmacokinetics-Plasma level of XW001(Baseline, Day 8)
研究者
研究点 (1)
Loading locations...
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