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A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects

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Trial Profile

A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Jun 2023

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At a glance

  • Drugs Rilogrotug (Primary) ; Rilogrotug (Primary)
  • Indications Cachexia
  • Focus Adverse reactions; First in man
  • Sponsors AVEO Oncology

Most Recent Events

  • 08 Jun 2023 Status changed from active, no longer recruiting to completed.
  • 14 Mar 2022 According to an AVEO Oncology media release, operational errors at the trial site have caused data integrity concerns and company has notified the FDA to confirm the suitability of the data for regulatory purposes and whether AVEO may publish the data from this trial.
  • 14 Mar 2022 According to an AVEO Oncology media release, last patient was dosed in this study.

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