Safety and blood levels of repeated IRL201104, version 1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, parallel group study in healthy volunteers to assess the safety, tolerability and pharmacokinetics of multiple ascending doses of IRL201104 to support a future COVID-19 patient study. HMR code (20-018)

• IRAS ID

  292734

• Contact name

  Naomi Dugdale

• Contact email

  naomi.dugdale@immuneregulation.com

• Sponsor organisation

  Revolo Biotherapeutics Ltd

• Eudract number

  2020-005428-12

• Clinicaltrials.gov Identifier

  NCT04748536

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Summary Of Research
  The study medicine (IRL201104) is an experimental treatment for COVID 19-related Acute Respiratory Distress Syndrome (ARDS).

  COVID-19 is a viral infectious disease caused by a new strain of coronavirus (SARS-CoV-2). Most people with COVID-19 have only a mild illness and recover without medical treatment. Some people, in particular the elderly or those with existing health problems, may develop COVID-19 associated pneumonia, which can trigger ARDS and cause lung failure. Lung failure from ARDS is the leading cause of COVID 19 related deaths. A key mechanism of ARDS is when too many neutrophils (a type of white blood cell that helps fight infection) enter the lungs, causing inflammation and a build-up of fluid and mucus. In animal studies, the study medicine reduces neutrophils and inflammation in the lung. If the same occurs in humans with COVID-19, it may improve a patient’s chance of survival.

  We’re doing this study to find out the side effects and blood levels of the study medicine in healthy participants before it’s tested in COVID-19 patients. We’ll also study how the body reacts to the study medicine and whether it develops antibodies to it.

  We’ll give up to 38 healthy participants aged 18–65 years, once-daily doses for up to 7 days. We’ll start with a low dose and increase the dose as the study progresses.
  Participants will take up to 8 weeks to finish the study. They’ll make 4 outpatients visits, 1 telephone follow-up call and stay on the ward for up to 9 nights.

  A pharmaceutical company, Immune Regulation, is funding the study.

  The study will take place at 1 centre in London.

  Summary Of Results
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbd0sGhZOSr2DsjYgtwd7GF6tX561tZADlIw7a0gBbhcRV5JiLKj-2BkEubcR97BOz8YnnQ9JdjID9AvuXmOeD0QsMyTk84t8Vg0vNzoPQ8XkIZDChacNEJV77WUpQZhFYLBuNh88RfWTbOVopOJIp8EXW6NlUxNib35IAyo0AIiaWjI-2BD3-2Fte-2F9XWBfyCNkx5-2FLJ8WBQumaNrEQ6h-2Fu8TTWn8-3DF2f3_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK8T9VBVLEe75-2FCNKMuGgE6FCGOf-2FzRMO9ZfW9HY3CHi-2BbOCZqr-2Fegg-2BLDMPhOB73pPcm6PsWEnslBn00IhUk681AQl077VuLAW-2BBGogi-2FVcK9CZDCGaRwb0IL5O0cnaKrSyA-2FJTlpZ4hhwW4Zujbu8ORSztzQc9zdg497-2FI3lscg-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C68c7a8890b6e4fbe368208d9fb8cd5ee%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637817404563747759%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=CQVtfqjb%2BWVZZT96q5IC142g7epC16kMLvWH%2BhigopM%3D&reserved=0

• REC name

  North East - York Research Ethics Committee

• REC reference

  21/NE/0014

• Date of REC Opinion

  14 Jan 2021

• REC opinion

  Favourable Opinion