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A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications

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Trial Profile

A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2025

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At a glance

  • Drugs CD 388 (Primary)
  • Indications Influenza A virus infections; Influenza B virus infections; Influenza virus infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NAVIGATE
  • Sponsors Cidara Therapeutics

Most Recent Events

  • 03 Sep 2025 According to a Cidara Therapeutics media release, the company announced that the data from the study will be shared during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP). The conference is taking place September 17-20, 2025, in Singapore.
  • 23 Jun 2025 According to a Cidara Therapeutics media release, Cidara has submitted an end of Phase 2 meeting request to the FDA to review the Phase 2b results and further discuss the Phase 3 trial design and start time.
  • 23 Jun 2025 Primary endpoint (Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring 7 Days after and up to 24 Weeks after Administration of Study Drug) has been met as per Cidara Therapeutics media release

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