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Recruiting Phase 2/3

A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.

NCT07658534 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2/3
Started
2026-03-03
Last updated
2026-06-22

Condition(s) studied

Respiratory Syncytial Virus Infections

Investigational drug(s) / intervention(s)

Ziresovir (AK0529) →Placebo

Ziresovir (AK0529): Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral

Placebo: Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral

Study summary

Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18-85 years (inclusive), regardless of gender. * Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose. * Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years. * Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale). * Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom/sign confirmed by investigator; pre-existing symptoms are those due to underlying conditions) Exclusion Criteria: * Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent. * Suspected bacterial co-infection. * Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study. * Received prohibited medications, or plans to use prohibited medications during the study. * Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy. * Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation. * Female participants with a positive pregnancy test result, or who are breastfeeding. * Refusal to use effective contraception during the trial period.

Primary outcome measure(s)

  • Time from first dose to resolution of LRTD symptoms — Up to Day 27
    LRTD symptoms (cough, shortness of breath, wheezing, expectoration) are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39.

Trial sites (9)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting
Guangzhou Medical University Panyu Central Hospital Guangzhou Guangdong Not Yet Recruiting
Cangzhou Hospital of Integrated TCM-WM Cangzhou Hebei Recruiting
The First Affiliated Hospital of Nanyang Medical College Nanyang Henan Recruiting
Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou) Zhengzhou Henan Not Yet Recruiting
Wuhan Sixth Hospital Wuhan Hubei Recruiting
Zhejiang Hospital Hangzhou Zhejiang Not Yet Recruiting
People's Hospital of Rui'an City Rui’an Zhejiang Recruiting
Taizhou Hospital of Zhejiang Province Taizhou Zhejiang Recruiting

More Shanghai Ark Biopharmaceutical Co., Ltd. trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07658534 on ClinicalTrials.gov ↗ ← All trials in Japan