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A Randomized, Double-Blind, Placebo-Controlled Phase 1a/1b Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of ARDS-003 in Hospitalized COVID-19 Patients with Pneumonia and at Risk of Developing Acute Respiratory Distress Syndrome

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A Randomized, Double-Blind, Placebo-Controlled Phase 1a/1b Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of ARDS-003 in Hospitalized COVID-19 Patients with Pneumonia and at Risk of Developing Acute Respiratory Distress Syndrome

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 01 Jun 2021

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At a glance

  • Drugs Onternabez (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections; COVID-19 pneumonia
  • Focus Adverse reactions
  • Sponsors Tetra Bio Pharma

    • Most Recent Events

    • 28 May 2021 According to a Tetra Bio Pharma media release, Batches of ARDS-003 have been manufactured over the last several months allowing Tetra to create the chemistry, manufacturing and controls information required to submit the USA Investigational New Drug (IND).
    • 28 May 2021 According to a Tetra Bio Pharma media release, the company has completed a consultation process with both the U.S. FDA and Health Canada (HC) for ARDS-003 and based on feedback from Health Canada the Phase 1a and 1b protocols were modified to a single protocol with an adaptive study design. Study will be initiated at six sites.
    • 12 Apr 2021 New trial record

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