Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A
NCT ID: NCT04024137
Last Updated: 2020-06-04
Study Results
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Basic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2019-12-07
2020-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
ZSP1273 200 mg
1 X 200-mg tablet taken orally
Placebo
2 tablets taken orally
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.
ZSP1273-400 mg
2 X 200-mg tablet taken orally
Placebo
1 tablet taken orally
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) .
ZSP1273-600 mg
3 X 200-mg tablet taken orally
Placebo
3 tablets taken orally
Placebo
Subjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
Placebo
Subjects will receive matching placebo of ZSP1273
Interventions
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ZSP1273 200 mg
1 X 200-mg tablet taken orally
Placebo
2 tablets taken orally
ZSP1273-400 mg
2 X 200-mg tablet taken orally
Placebo
1 tablet taken orally
ZSP1273-600 mg
3 X 200-mg tablet taken orally
Placebo
3 tablets taken orally
Placebo
Subjects will receive matching placebo of ZSP1273
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
5. 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.
Exclusion Criteria
2. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
3. 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.
4. Patients who have received influenza vaccine within 6 months prior to enrollment.
5. Presence of clinically significant abnormalities in ECG .
6. Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
7. Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
8. White blood cells(WBC)\>10.0×109/L at screening.
9. Subject who produces purulent sputum or has suppurative tonsillitis.
10. 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.
11. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \[HIV\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
12. Concomitant therapy with aspirin or salicylic acid.
13. Morbid obesity(Body mass index \[BMI\]≥30kg/m2).
14. Known history of alcohol abuse or drug abuse.
15. 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.
16. Have received any other investigational products within 3 months prior to dosing.
17. Subjects who should not be included in the study in the opinion of the Investigator.
18 Years
65 Years
ALL
No
Sponsors
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Guangdong Raynovent Biotech Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Dongguan people's Hospital
Dongguan, Guangdong, China
Nanfang Hospital,South Medical Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
Traditional Chinese Medicine Hospital of Guangdong Province
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital Of Guangdong Medical University
Zhanjiang, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Sixth People's Hospital Of Zhengzhou
Zhengzhou, Henan, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu, China
Jiujiang University Hospital
Jiujiang, Jiangxi, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital,Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Yang Z, Li Z, Zhan Y, Lin Z, Fang Z, Xu X, Lin L, Li H, Lin Z, Kang C, Liang J, Liang S, Li Y, Li S, Yang X, Ye F, Zhong N; Onradivir Trial Recruitment and Medical Monitoring Group. Safety and efficacy of onradivir in adults with acute uncomplicated influenza A infection: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2024 May;24(5):535-545. doi: 10.1016/S1473-3099(23)00743-0. Epub 2024 Feb 5.
Other Identifiers
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ZSP1273-18-02
Identifier Type: -
Identifier Source: org_study_id
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