A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 26
- 主要终点
- Time to alleviation of influenza symptoms in participants
研究概览
简要总结
The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and female subjects between 18-65 years (Both inclusive).
- •Patients with a diagnosis of influenza virus A infection confirmed by all of the following:
- •Positive Rapid Antigen Test (RAT) with throat swabs;and
- •Fever≥38.0ºC (axillary) in the predose examinations;and
- •At least one of the following general systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:
- •General systemic symptoms:Headache,Feverishness or chills,Muscle or joint pain,Fatigue;
- •Respiratory symptoms:Cough,Sore throat,Nasal congestion.
- •The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:
- •Time of the first increase in body temperature(axillary temperature≥38.0ºC),or
- •Time when the patient experiences at least one general or respiratory symptom.
- •Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
- •Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
排除标准
- •Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to ZSP1273;
- •Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- •Use of the following medications within 7 days prior to screening:
- •Influenza antiviral medication:oseltamivir,peramivir,famivir,abidol,amantadine or rimantadine.
- •Chinese patent medicine or herbal medicine with antiviral effect.
- •Patients who have received influenza vaccine within 6 months prior to enrollment.
- •Presence of clinically significant abnormalities in ECG .
- •Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
- •Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
- •White blood cells(WBC)>10.0×109/L at screening.
- •Subject who produces purulent sputum or has suppurative tonsillitis.
- •Patients with severe or uncontrollable underlying diseases:blood disorders,severe chronic obstructive pulmonary disease(COPD),liver disorders(ALT or AST≥3 ULN,total bilirubin≥1.5 ULN),kidney disorders(serum creatinine>177μmol/L or 2mg/dL),chronic congestive heart failure(NYHA III-IV),mental disorders.
- •Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
- •Concomitant therapy with aspirin or salicylic acid.
- •Morbid obesity(Body mass index [BMI]≥30kg/m2).
- •Known history of alcohol abuse or drug abuse.
- •Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
- •Have received any other investigational products within 3 months prior to dosing.
- •Subjects who should not be included in the study in the opinion of the Investigator.
研究组 & 干预措施
ZSP1273-200 mg BID
Subjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
干预措施: ZSP1273 200 mg (Drug)
ZSP1273-200 mg BID
Subjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
干预措施: Placebo (Drug)
ZSP1273-400 mg BID
Subjects will receive 10 doses of ZSP1273 400mg（200mg*2) along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
干预措施: ZSP1273-400 mg (Drug)
ZSP1273-400 mg BID
Subjects will receive 10 doses of ZSP1273 400mg（200mg*2) along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
干预措施: Placebo (Drug)
ZSP1273-600 mg QD
Subjects will receive 5 doses of ZSP1273 600mg （200mg *3) and 5 doses of placebo respectively for 5 days.The interval between ZSP1273 and placebo is approximately 12 hour (+/- 2) .
干预措施: ZSP1273-600 mg (Drug)
ZSP1273-600 mg QD
Subjects will receive 5 doses of ZSP1273 600mg （200mg *3) and 5 doses of placebo respectively for 5 days.The interval between ZSP1273 and placebo is approximately 12 hour (+/- 2) .
干预措施: Placebo (Drug)
Placebo
Subjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to alleviation of influenza symptoms in participants
时间窗: Initiation of study treatment (Day 1) up to Day 15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all 7 influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
次要结局
- AUC of the log10 pharyngeal viral load(Days 6)
- Change in the total score of 7 influenza symptoms(Up to Day15)
- Time to Resolution of Fever(Up to Day15)
- Incidence of influenza-related complications(Up to Day21)
- Time to return to normal activities of daily life(Up to Day15)
- Change in EQ-5D-5L(Baseline up to Day 15)
- Time to alleviation of each influenza symptom.(Up to Day15)
- Proportion of patients reporting normal temperature(Up to Day15)
- Proportion of patients with the Serological conversion of neutralizing antibody titer relative to that in Visit 1 ≥4(Baseline and Day 21)
- Proportion of patients and frequency in combination use of acetaminophen.(Up to 21 days post-dose)
- Percentage of subjects with virus titer detected(Days 2,4, 6)
- Duration of detectable virus(Days 2,4, 6)
- Change in virus titer(Days 2,4, 6)
- Change in viral RNA load(Days 2,4, 6)