A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.
This is a multicenter, randomized, double-blind, controlled Phase III clinical study.
The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients aged 2 to 11 years at screening, both sex;
- •2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
- •3. Parents willing and able to comply with study requirements, under the judgment of investigators .
- •4. Onset of symptoms no more than 48 hours before presentation for screening.
排除标准
- •1. Patients with severe influenza.
- •2. Pregnant or breast-feeding females
- •3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
- •4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
- •5. Other antiviral therapy is required during screening.
研究组 & 干预措施
Oseltamivir granules (Part 2B)
Around 10 patients, 2-4 years old.
干预措施: Placebo of ADC189 granules (Drug)
ADC189 tablets Group (Part 1)
Around 30 patients, 6-11 years old.
干预措施: ADC189 tablets (Drug)
ADC189 tablets Group (Part 1)
Around 30 patients, 6-11 years old.
干预措施: Placebo of Baloxavir Marboxil tablets (Drug)
Baloxavir marboxil tablets Group (Part 1)
Around 15 patients, 6-11 years old.
干预措施: Baloxavir Marboxil tablets (Drug)
Baloxavir marboxil tablets Group (Part 1)
Around 15 patients, 6-11 years old.
干预措施: Placebo of ADC189 tablets (Drug)
ADC189 granules Group (Part 2A)
Around 60 patients, 5-11 years old.
干预措施: Placebo of Baloxavir Marboxil tablets (Drug)
ADC189 granules Group (Part 2A)
Around 60 patients, 5-11 years old.
干预措施: ADC189 granules (Drug)
Baloxavir marboxil tablets (Part 2A)
Around 30 patients, 5-11 years old.
干预措施: Baloxavir Marboxil tablets (Drug)
Baloxavir marboxil tablets (Part 2A)
Around 30 patients, 5-11 years old.
干预措施: Placebo of ADC189 granules (Drug)
ADC189 granules (Part 2B)
Around 20 patients, 2-4 years old.
干预措施: ADC189 granules (Drug)
ADC189 granules (Part 2B)
Around 20 patients, 2-4 years old.
干预措施: Placebo of Oseltamivir granules (Drug)
Oseltamivir granules (Part 2B)
Around 10 patients, 2-4 years old.
干预措施: Oseltamivir granules (Drug)
结局指标
主要结局
The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 up to 15 days
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
次要结局
- Plasma Concentrations of ADC189 and ADC189-I07(From Day 1 up to 14 days, 4 time points.)
- Time to Resolution of Influenza Symptoms(From Day 1 up to 14 days)