Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06775405

A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants

A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

Conditions Respiratory Synctial Virus Infections

Interventions AK0529 Placebo

Updated 1 time since 2025 Last updated: Jan 9, 2025 Started: Feb 29, 2024 Primary completion: Aug 31, 2025 Completion: Sep 30, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Respiratory Synctial Virus Infections, this trial is actively recruiting participants. The trial is conducted by Shanghai Ark Biopharmaceutical Co., Ltd. and has accumulated 1 data snapshot since 2024. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

1 version recorded

Recruiting — PHASE3 [monthly]

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Shanghai Ark Biopharmaceutical Co., Ltd.

Data source: Shanghai Ark Biopharmaceutical Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Beijing, China , Changchun, China , Changsha, China , Chengdu, China , Hangzhou, China , Sanya, China , Shanghai, China , Shenyang, China , Tianjin, China , Wenzhou, China and 4 more locations