Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A

NCT04024137 | Completed Phase 2

• 1 other identifier: ZSP1273-18-02
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 26

Brief Summary

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.

Conditions

Influenza A

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of influenza symptoms in participants

  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

  Initiation of study treatment (Day 1) up to Day 15

Secondary Outcomes (14)

• AUC of the log10 pharyngeal viral load

  Days 6

• Change in the total score of 7 influenza symptoms

  Up to Day15

• Time to alleviation of each influenza symptom.

  Up to Day15

• Time to Resolution of Fever

  Up to Day15

• Proportion of patients reporting normal temperature

  Up to Day15

Study Arms (4)

ZSP1273-200 mg BID

EXPERIMENTAL

Subjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.

Drug: ZSP1273 200 mg; Drug: Placebo

ZSP1273-400 mg BID

EXPERIMENTAL

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.

Drug: ZSP1273-400 mg; Drug: Placebo

ZSP1273-600 mg QD

EXPERIMENTAL

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) .

Drug: ZSP1273-600 mg; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Subjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.

Drug: Placebo

Interventions

ZSP1273 200 mg DRUG

1 X 200-mg tablet taken orally

ZSP1273-200 mg BID

Placebo DRUG

2 tablets taken orally

ZSP1273-200 mg BID

ZSP1273-400 mg DRUG

2 X 200-mg tablet taken orally

ZSP1273-400 mg BID

ZSP1273-600 mg DRUG

3 X 200-mg tablet taken orally

ZSP1273-600 mg QD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (26)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Luhe Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Location

Dongguan people's Hospital

Dongguan, Guangdong, China

Location

Nanfang Hospital,South Medical Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Traditional Chinese Medicine Hospital of Guangdong Province

Guangzhou, Guangdong, China

Location

Huizhou Municipal Central Hospital

Huizhou, Guangdong, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

Affiliated Hospital Of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

The Sixth People's Hospital Of Zhengzhou

Zhengzhou, Henan, China

Location

Sir Run Run Hospital Nanjing Medical University

Nanjing, Jiangsu, China

Location

Jiujiang University Hospital

Jiujiang, Jiangxi, China

Location

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Linyi People's Hospital

Linyi, Shandong, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Location

General Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 38330975 DERIVED

MeSH Terms

Interventions

ZSP1273

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: December 7, 2019
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: June 4, 2020

Record last verified: 2019-12

Locations

CN (26)