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A Randomized, Double-blind, Placebo-controlled, 2-part Study of Orally Administered AK0529 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Multiple Doses in Hospitalized Infants With Respiratory Syncytial Virus Infection

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, 2-part Study of Orally Administered AK0529 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Multiple Doses in Hospitalized Infants With Respiratory Syncytial Virus Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Feb 2024

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At a glance

  • Drugs Ziresovir (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms AirFLO
  • Sponsors Ark Biosciences

Most Recent Events

  • 09 Dec 2022 Results presented in in an Ark Biosciences Media Release.
  • 09 Dec 2022 According to an Ark Biosciences media release, the National Medical Products Administration of China has formally accepted the marketing authorization application (NDA) of the new drug Elsevier for the treatment of respiratory syncytial virus (RSV) infection, and included it in the Priority Review and Approval program.
  • 07 Apr 2022 According to Ark Biosciences media release, supported by the AirFLO results, regulatory submission of ziresovir for market approval in China is planned in Mid-2022.

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