MP0420 - first doses in humans, version 1 [COVID-19]
Research type
Research Study
Full title
A phase 1, randomised, double-blind, placebo-controlled, first-time-in-human single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered MP0420 in healthy volunteers
IRAS ID
289269
Contact name
Nicolas Leupin
Contact email
Sponsor organisation
Molecular Partners AG
Eudract number
2020-004365-39
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Summary of Research
The study medicine (MP0420) is an experimental treatment for COVID-19, a viral infectious disease caused by a new strain of coronavirus (SARS-CoA-2). Once the virus enters the body, it quickly replicates (‘makes copies of itself’) inside cells in the lung, causing a viral infection. Most people infected with COVID-19 have only a mild illness and recover without medical treatment. But some people, particularly older people or those with existing health problems, can become seriously ill. The main symptoms of COVID-19 are: fever; dry cough; loss of/change in the sense of smell or taste; tiredness; and aching muscles\n\nWe’ll give up to 40 healthy volunteers, aged 18–65 years, single doses of the study medicine. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out if the study medicine is safe and well-tolerated, the blood levels after dosing, and whether the body makes antibodies to it.\n\nParticipants will take up to 14 weeks to finish the study. They’ll make up to 8 outpatient visits, and stay on the ward for 3 nights.\n\nA pharmaceutical company Molecular Partners is funding the study.\n\nThe study will take place at 1 centre in London.\nREC name
London - Hampstead Research Ethics Committee
REC reference
20/HRA/4562
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion