Open Orphan plc announced the world’s first COVID-19 characterization study has received approval from a specially convened Research Ethics Committee (REC). This news follows the announcement on October 20, 2020 of Open Orphan subsidiary hVIVO’s contract with the UK Government to develop a COVID-19 human challenge study model. The initial virus characterization study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment. The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust’s specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterization study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London. The REC approval completes all the independent external body approvals required before the study can commence.