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A Phase 1, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Cardiovascular Evaluations of PPP003 in Healthy Volunteers

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Trial Profile

A Phase 1, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Cardiovascular Evaluations of PPP003 in Healthy Volunteers

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2020

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At a glance

  • Drugs Onternabez (Primary)
  • Indications Acute lung injury; Adult respiratory distress syndrome; COVID 2019 infections; Cytokine release syndrome; Dry eyes; Proliferative vitreoretinopathy; Sepsis; Uveitis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Tetra Bio Pharma

Most Recent Events

  • 16 Jul 2020 According to a Tetra Bio Pharma media release, the company expects to start this study in late September 2020. The treatment phase of the study should be completed within the two months followed by the analysis and reporting phase. The company's plan is to obtain preliminary efficacy data from this small well-controlled clinical trial as soon as possible.
  • 16 Jul 2020 According to a Tetra Bio Pharma media release, the FDA stated that the nonclinical program was appropriate to support initiating this phase 1 study. The FDA also provided detailed feedback on the proposed Phase 1 and 2 clinical trial protocols.
  • 16 Jul 2020 According to a Tetra Bio Pharma media release, the U.S. Food and Drug Administration(FDA) has favorably reviewed the company's Pre-Investigational New Drug (PIND) application for ARDS-003 to be studied in COVID-19 patients at risk of developing acute respiratory distress syndrome(ARDS) and provided positive feedback. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program(CTAP).

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