A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered AK0529 in Adults With Respiratory Syncytial Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 22
- 主要终点
- Change of symptom score
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered AK0529 in Chinese adults with RSV infection.
详细描述
This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study in Chinese adult outpatients with RSV infection. Approximately 160 eligible patients who have been recently diagnosed with RSV infection are planned to be enrolled into the study. Symptom scores of patients before and after treatment will be evaluated. Meanwhile, nasopharyngeal samples and blood samples will be collected for virological and pharmacokinetics evaluations. The evaluation of the safety and tolerability will include AE/SAE, vital signs, physical examination, laboratory examination and 12-lead ECGs. The total study duration for each patient will be 20 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years, inclusive.
- •Confirmed with RSV infection by rapid diagnostic testing.
- •New onset with documentation of the following symptoms within 72 hours prior to the start of screening: Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath; Systemic symptoms: headache, fatigue / lethargy, fever, and muscle and / or joint ache. The patient must have four symptoms of above, and at least one of these must be respiratory symptom in nature.
- •Able and willing to provide written informed consent and to comply with the study protocol.
排除标准
- •The patient has taken, is taking or needs to take any antiviral medication (e.g. ribavirin, Chinese medicine or herbs with effects of treating respiratory tract infection) within the 72 hours prior to screening.
- •Awareness of concomitant infections of respiratory viruses (eg, influenza A, B), bacterial or fungal infections, including systemic bacterial or fungal infections within 7 days prior to screening or during the screening period.
- •Patient frailty was evaluated as "Vulnerable" or worse according to the Clinical Frailty Scale with a score ≥ 4 at screening.
- •Awareness of having positive results on HBsAg or HCV antibody or HIV (HIV 1 or HIV 2).
- •Patient with active tuberculosis or is taking antituberculosis treatment.
- •Patient with severe gastrointestinal disease which could impact drug absorption, eg, vomiting, malabsorption syndrome, or short bowel syndrome caused by necrotizing enterocolitis.
- •Patient with any congenital heart disease, acute or chronic heart failure, ischemic heart disease, or congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation.
- •Patient with malignant tumor.
- •Patient has received or is waiting for bone marrow, stem cell or solid organ transplantation.
- •Patient with any immune-related disease to be treated within 12 months prior to screening.
- •Patient with clinical laboratoy test values of ≥ 2x the upper limit of normal (ULN) for alanine aminotransferase or aspartate aminotransferase, or >1x ULN for total bilirubin, or >1.5xULN for serum creatinine.
- •Patient with electrolyte disorders, eg, hypokalemia, hypocalcemia, or hypomagnesemia.
- •Patient with history of drug or alcohol abuse within 12 months prior to screening ("alcohol abuse" definition is >14 units per week: 1 unit = 10mL Alcohol, or 250mL of 4% beer, or 25 mL of 40% spirit, or 75 mL of 13% wine).
- •Patient has allergy or hypersensitivity to study medication or its compositions.
- •Female patient with positive pregnancy test result or is lactating.
- •Patient with fertility refusing to use medically effective contraceptives during the study or within three months of the end of study.
- •Patient participated in an investigational drug or device study within 60 days prior to screening.
- •Patient who in the opinion of the investigator, is deemed as ineligible for the study, including patients who are with active psychiatric disease, or are taking psychiatric medication.
研究组 & 干预措施
Placebo Arm
Patients randomised into this arm will be orally administered with placebo q.d. for five days.
干预措施: Placebo (Drug)
300mg AK0529 Arm
Patients randomised into this arm will be orally administered with 300mg AK0529 q.d. for five days.
干预措施: AK0529 (Drug)
100mg AK0529 Arm
Patients randomised into this arm will be orally administered with 100mg AK0529 q.d. for five days.
干预措施: AK0529 (Drug)
200mg AK0529 Arm
Patients randomised into this arm will be orally administered with 200mg AK0529 q.d. for five days.
干预措施: AK0529 (Drug)
结局指标
主要结局
Change of symptom score
时间窗: From Day 0 to Day 5
To evaluate the change of patient-reported symptom score in AK0529 arms compared with the change in placebo arm after treatment. The scale is Wang bronchiolitis score and the total score is reported with a range from 0 to 12. A decreasing value of total score represents clinical improvement. Subscales are not applicable in this symptom score.
Subject withdrawals due to treatment-emergent adverse events
时间窗: From Day -3 to Day 14
A treatment-emergent adverse event (TEAE) is an AE that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state.
Incidence of adverse events during the study
时间窗: From Day -3 to Day 14
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
次要结局
- Area under curve change of viral load(From Day 0 to Day 5)