Study of Safety, Tolerability and PK of MAS825 in Healthy Volunteers
Research type
Research Study
Full title
A first-in-human, randomized, subject-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers
IRAS ID
290317
Contact name
Sarah Cross
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003944-95
Duration of Study in the UK
0 years, 9 months, 21 days
Research summary
The Sponsor is developing the test medicine, MAS825, for the potential treatment of inflammatory conditions.
This is a first-in-human study in healthy non-Japanese volunteers and Japanese volunteers involving administration of single ascending doses of MAS825. Eligible subjects will be randomised to receive a single dose of either MAS825 or placebo (dummy test medicine containing no drug). Safety, pharmacokinetics (level of MAS825 in the blood over time), pharmacodynamics (effect of MAS825 on the body) and immunogenicity (ability to produce an immune response) will be assessed for each subject. A blood sample will also (optionally) be taken for exploratory genetic research.
The study is designed to include a maximum of 13 cohorts. Six cohorts of this study have already been completed in the United States of America (USA). Due to the COVID-19 situation in the USA the Sponsor has chosen to open the trial at a UK site. Four cohorts are planned at the UK site, two of which will involve administration of MAS825 or placebo to healthy non-Japanese volunteers. The other two cohorts will involve administration of MAS825 or placebo specifically to healthy Japanese volunteers.
The remaining cohorts are optional and are not expected to be conducted in either the USA or UK.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1274
Date of REC Opinion
21 Dec 2020
REC opinion
Further Information Favourable Opinion