A Study of subcutaneous KY1005 in Healthy Volunteers (19-018)
Research type
Research Study
Full title
A Phase I, open-label study to assess the pharmacokinetics of KY1005 after single dose administration by subcutaneous and intravenous route in healthy volunteers
IRAS ID
278495
Contact name
Adeep Puri
Contact email
Sponsor organisation
Kymab Ltd
Eudract number
2019-004524-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The study medicine is an experimental new medicine being developed for treating immune system diseases such as atopic dermatitis (AD), a type of eczema. The study medicine contains a large protein called a ‘monoclonal antibody’, which is made specifically for use in humans. It is designed to attach (‘stick’) to and block the activity of a particular protein (OX40L) which plays a role in increased inflammation. This study medicine is currently being tested in patients with AD to assess whether it is effective at reducing inflammation, and to look for side effects when it’s used to treat immune diseases.
The study medicine has already been tested when given by slow infusion into a vein. But, when the study medicine is given by slow infusion into a vein, it has to be done by a doctor or nurse. So we’d now like to test the study medicine when it’s injected under the skin, so patients should be able to dose themselves.
We aim to find out the side effects and blood levels of the study medicine given as subcutaneous injections (injections under the skin) in healthy men. We’ll also study any side effects of the study medicine and whether the body makes proteins called antibodies against it.
We’ll give 24 healthy men, aged 18–45, single doses of the study medicine, by slow infusion into a vein (Group 1) or by injection under the skin (Groups 2 and 3).
Participants will take up to 14 weeks to finish the study. They’ll make up to 9 outpatient visits and a stay on the ward for up to 2 nights (Group 1) or up to 5 nights (Groups 2 and 3).
A pharmaceutical company (Kymab) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
20/NI/0018
Date of REC Opinion
15 Apr 2020
REC opinion
Further Information Favourable Opinion