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A phase I clinical study, examining the safety, tolerability and pharmacokinetics of casirivimab and imdevimab in Japanese people

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Trial Profile

A phase I clinical study, examining the safety, tolerability and pharmacokinetics of casirivimab and imdevimab in Japanese people

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Nov 2021

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At a glance

  • Drugs Casirivimab/imdevimab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 05 Nov 2021 According to a Chugai Pharma Europe media release, the Ministry of Health, Labour and Welfare (MHLW) has approved RONAPREVE for the additional indication of the prevention of symptomatic SARS-CoV-2 infection (COVID-19), based on the results from REGN-COV 206,REGN-COV 20145 and JV43180 studies. The Special Approval for Emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval
  • 21 Jul 2021 New trial record
  • 20 Jul 2021 According to a Regeneron Pharmaceuticals media release, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab) for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.The MHLW is on based the approval on results from the global phase III REGN-COV 2067 as well as a phase I clinical study, examining the safety, tolerability and pharmacokinetics in Japanese people.

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