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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: 27 Jun 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

  • 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
  • 23 Jun 2025 According to a Cidara Therapeutics media release, Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.

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