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A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

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Trial Profile

A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Nov 2023

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At a glance

  • Drugs CD 388 (Primary) ; CD 388 (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; First in man
  • Sponsors Cidara Therapeutics

    • Most Recent Events

    • 09 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 27 Sep 2023 According to a Cidara Therapeutics media release, data from this study will be presented at IDWeek 2023
    • 06 Sep 2023 According to a Cidara Therapeutics, following promising interim efficacy and safety data from ongoing Phase 1 and 2a trials, the Janssen Pharmaceutical, has delivered to Cidara its Election to Proceed Notice for CD388 which is being developed for the universal prevention of influenza A and B. Responsibility for future development, manufacturing and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement.

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