NCT04231968已完成3 期
A Randomized, Double-blind, Placebo-controlled, 2-part Study of Orally Administered AK0529 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Multiple Doses in Hospitalized Infants With Respiratory Syncytial Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 28
- 主要终点
- Clinically significant change from baseline in bronchiolitis score on Day 3
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter, phase III study to be conducted in infants hospitalized with RSV infection in China. The main objectives of this study are to investigate the efficacy and safety of AK0529 in Chinese infants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 patients of any ethnicity with an age-adjusted for any prematurity of ≥1 month and ≤24 months.
- •Diagnosis of RSV infection by any virological means within 36 hours preceding the initial dose.
- •The time from the onset caused by RSV infection to the first dose should be ≤ 7 days. Time of onset is defined as the time the first respiratory or systemic signs or symptoms of RSV infection confirmed by the investigator.
- •Body weight ≥ 2.5 kg and ≤ 20 kg at screening.
- •For patients aged <12 months, an occipitofrontal head circumference should be within the normal range for age and gender.
- •Bronchiolitis score ≥
- •The parent/legal guardian must have provided written informed consent for the patient to participate.
排除标准
- •Patients who have used any prohibited medications within 72 hours prior to expected administration and those who have used inhaled or systemic glucocorticosteroids within 24 hours prior to administration.
- •Patients (or mothers of patients younger than 6 months of age) with a known HIV-positive history or patients highly suspected HIV-positive by the investigator.
- •Patients with known co-infection with influenza virus.
- •Patient known to have pneumonia caused by bacterial infection.
- •Patients requiring vasopressors or vasoactive drugs at the time of enrollment.
- •Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product.
- •Bronchopulmonary dysplasia requiring assisted ventilation at the time of enrolment, except for the result of RSV infection.
- •Patients at risk for hypercapnia based on their medical history, except for the result of RSV infection.
- •Patient with airway malformations and congenital heart diseases, except for isolated patent ductus arteriosus and/or patent foramen ovale.
- •Renal failure including renal abnormalities likely to be associated with renal insufficiency.
- •Clinical evidence of hepatic decompensation.
- •Symptomatic because of congenital metabolic abnormality.
- •Chronic or persistent feeding difficulties.
- •Known or suspected to have primary immunodeficiency disease.
- •Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline, or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment; in case of any question, discuss such cases with the sponsor's medical monitor.
- •A history of epilepsy or seizures including febrile seizures.
- •History of family history of high allergies or allergies to multiple substances, or presence of severe rash that in the opinion or the investigator renders the patient unsuitable for enrollment.
- •The patient's parent or guardian is an employee of the investigator or the study site with direct involvement in the proposed study or other studies under the direction of that investigator of the study site, or any family members of the employees or the investigator.
- •Participation in an investigational drug or device study within 30 days prior to the date of screening.
- •Failure to satisfy the investigator of fitness to participate for any other reason.
研究组 & 干预措施
AK0529
Experimental
Participants who are randomized to the experimental arm will receive AK0529 twice daily for five days .
干预措施: AK0529 (Drug)
Placebo
Placebo Comparator
Participants in the control arm will be administered placebo at the matching dosage levels of active medications.
干预措施: Matching placebo of AK0529 (Drug)
结局指标
主要结局
Clinically significant change from baseline in bronchiolitis score on Day 3
时间窗: From Baseline (Pre-dose on Day 1) to Day 3 (48 hours)
To demonstrate that AK0529 is superior to placebo in terms of changes from baseline in bronchiolitis signs and symptoms score. The differences of change in the bronchiolitis score are to be evaluated between the AK0529 and placebo arms after treatment. The total score is reported with a range from 0 to 12. Generally, each score component has a range of values from 0 to 3. A decreasing value of the total score represents a clinical improvement. Unless otherwise noted, the last non-missing measurement/assessment before the first dose of the investigational product is defined as the Baseline measurement. If a measurement/evaluation is performed on the same day of the first dose of the investigational product, these measurements will be considered as Baselines.
次要结局
- Proportion of subjects who withdraw from the study due to AEs during the study(From Baseline to Day 14)
- Proportions of subjects with symptom remission at other visits after treatment(From Baseline (Pre-dose on Day 1) to Day 14 (except for Day 3))
- Proportions of subjects with disease remission on Day 3 after treatment(From Baseline (Pre-dose on Day 1) to Day 3 (48 hours))
- Proportions of subjects with the change in bronchiolitis sub-score values at each visit after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Proportions of subjects with RSV VL below the lower limit of quantification (LLOQ) on Day 5 after treatment(Day 5 (96hours))
- Proportion of subjects with serious adverse events (SAEs) occurring during the study(From Baseline to Day 14)
- Maximum plasma concentration of AK0529 (Cmax)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
- Plasma drug trough concentration of AK0529 (Ctrough)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
- Proportions of subjects with a reduction from baseline in clinical bronchiolitis score ≥ 3 after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Proportions of subjects with ≥ 75% reduction from baseline in bronchiolitis score on Day 3 after treatment(Day 3 (48 hours))
- Proportions of subjects with ≥ 75% reduction from baseline in bronchiolitis score at other visits after treatment(From Baseline (Pre-dose on Day 1) to Day 14 (except for Day 3))
- Proportions of subjects achieving a ≥ 90% reduction from baseline in bronchiolitis score after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Respiratory sequelae of subjects from the end of the safety observation period to the end of the second year(From Day 14 to end of Year 2)
- Proportions of subjects with a reduction from baseline in clinical bronchiolitis score ≥ 5 after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Time from the first dose to a ≥ 75% reduction in bronchiolitis score(From Baseline (Pre-dose on Day 1) to Day 14)
- Change from baseline in bronchiolitis sub-score at each visit after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Proportions of subjects achieving a ≥ 50% reduction from baseline in bronchiolitis score after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Analysis of subjects admitted to intensive care unit (ICU) for diseases related to RSV infection(From Baseline to the end of ICU)
- Analysis of subjects receiving supplemental oxygen therapy(From first treatment to Day 14)
- Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
- Proportions of subjects with a reduction from baseline in clinical bronchiolitis score ≥ 2 after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Proportions of subjects with disease remission at other visits after treatment.(From Baseline (Pre-dose on Day 1) to Day 14 (except for Day 3))
- Time from the first dose to symptom remission(From Baseline (Pre-dose on Day 1) to Day 14)
- Time from the first dose to a zero general symptom score for subjects with general symptoms sub-scores equal to 3 at baseline(From Baseline (Pre-dose on Day 1) to Day 14)
- Change in bronchiolitis score and percentage change from baseline at each visit after treatment (except Day 3)(From Baseline (Pre-dose on Day 1) to Day 14 (except Day 3))
- Proportions of subjects with RSV VL below the LLOQ at other visits(From Baseline (Pre-dose on Day 1) to Day 14 (except Day 5))
- Area under the curve of RSV VL from baseline to the last measurement(From Baseline (Pre-dose on Day 1) to Day 14)
- Analysis of clinical efficacy of AK0529 in different subgroups(From Baseline to Day 14)
- Apparent total body clearance (CL/F)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
- Change from baseline in RSV (Respiratory syncytial virus) VL(viral load ) on Day 5(From Baseline (Pre-dose on Day 1) to Day 5 (96 hours))
- Proportions of subjects with a reduction from baseline in clinical bronchiolitis score ≥ 4 after treatment(From Baseline (Pre-dose on Day 1) to Day 14)
- Proportions of subjects with symptom remission on Day 3 after treatment(Day 3 (48 hours))
- Time from the first dose to disease remission(From Baseline (Pre-dose on Day 1) to Day 14)
- Respiratory sequelae of subjects from the end of the safety observation period to Month 6(From Day 14 to Month 6)
- Change from baseline in RSV VL at each visit except Day 5 after treatment(From Baseline (Pre-dose on Day 1) to Day 14 (except Day 5))
- Proportion of subjects with adverse events (AEs) occurring during the study(From Baseline to Day 14)
- Analysis of subjects receiving non-invasive positive pressure ventilation or assisted mechanical ventilation(From Baseline to Day 14)
- Apparent volume of distribution (Vz/F)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
- Elimination half-life (t½)(At 3 and 24 hours after the first dose and on Day 6 (120 hours))
研究者
研究点 (28)
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