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AK0529

DRUG9 trials

Sponsors

Shanghai Ark Biopharmaceutical Co., Ltd.

Conditions

HealthyRESPIRATORY SYNCYTIAL VIRUS INFECTIONSRespiratory Synctial Virus InfectionsRespiratory Syncytial Virus Infections

Phase 1

Safety, Tolerability and PK Study of AK0529 in Healthy Human
CompletedNCT02297594
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Syncytial Virus Infections
Start: 2014-10-31End: 2015-06-30Updated: 2015-10-20
A Study of AK0529 in Infants Hospitalized With RSV
TerminatedNCT02460016
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Syncytial Virus Infections
Start: 2015-08-28End: 2015-11-03Updated: 2018-07-02
A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers
CompletedNCT03322800
Shanghai Ark Biopharmaceutical Co., Ltd.Healthy
Start: 2017-10-23End: 2018-05-24Updated: 2021-06-09
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
CompletedNCT03400995
Shanghai Ark Biopharmaceutical Co., Ltd.Healthy
Start: 2018-01-05End: 2018-08-30Updated: 2018-09-11

Phase 2

Viral Inhibition in Children for Treatment of RSV
CompletedNCT02654171
Shanghai Ark Biopharmaceutical Co., Ltd.RESPIRATORY SYNCYTIAL VIRUS INFECTIONS
Start: 2016-05-27End: 2019-04-09Updated: 2024-02-20
Anti-RSV Study in Chinese Patients (ASCENT)
TerminatedNCT03699202
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Syncytial Virus Infections
Start: 2019-03-28End: 2019-04-04Updated: 2026-06-22
A Study of AK0529 in Adults Patients Hospitalized With RSV Infection
CompletedNCT06942299
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Syncytial Virus Infections
Start: 2023-07-20End: 2024-06-28Updated: 2025-04-24

Phase 3

A Study of AK0529 in Chinese Infants Hospitalized With RSV
CompletedNCT04231968
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Syncytial Virus Infections
Start: 2020-09-22End: 2022-02-02Updated: 2024-02-13
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
RecruitingNCT06775405
Shanghai Ark Biopharmaceutical Co., Ltd.Respiratory Synctial Virus Infections
Start: 2024-02-29End: 2025-09-30Target: 180Updated: 2025-01-15

Related Papers

Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up.
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Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection
New England Journal of Medicine2024-09-2544 citations
EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus
The Journal of Infectious Diseases2024-09-236 citations
Safety and efficacy of AK0529 in respiratory syncytial virus‐infected infant patients: A phase 2 proof‐of‐concept trial
Influenza and Other Respiratory Viruses2023-07-0125 citations
A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein.
2020-01-2765 citations