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

NCT07658534 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-06-22

No results posted yet for this 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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

Ziresovir (AK0529)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658534 on ClinicalTrials.gov