LEVI-04 - first doses in humans; version 1
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single ascending dose, phase 1 study to evaluate the safety, tolerability and pharmacokinetics of LEVI-04 in healthy volunteers and patients with pain attributed to osteoarthritis of the knee. (HMR code: 17-502)
IRAS ID
227523
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Levicept Ltd
Eudract number
2017-000928-10
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
The study medicine, LEVI-04, is an experimental treatment for osteoarthritis (OA). OA is a disease where the surfaces within joints become damaged, so the joint doesn’t move as smoothly as it should, causing stiffness and pain. In conditions like OA, levels of a substance called nerve growth factor (NGF) are high, and it’s thought that this increases the amount of pain people feel. LEVI-04 contains a small part (fragment) of a protein that attaches to NGF, joined to a human antibody (antibodies are proteins made by the immune system in response to a foreign substance). We hope that the study medicine will reduce pain in OA and slow down the rate of the disease by attaching to and reducing the levels of NGF in the blood.
We’ll test single doses of LEVI-04 in up to 21 healthy volunteers and 35 patients with OA of the knee to find out its side effects, blood levels and effects on the body. LEVI-04 has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses.
There’ll be 8 groups, each of 7 participants; we’ll give single doses of LEVI-04 or placebo in each group. We’ll enrol healthy volunteers into the first 3 groups, and patients with OA of the knee into the remaining 5 groups.
All participants will have a stay on the ward for 4 nights. Healthy volunteers will make up to 6 outpatient visits and take up to 12 weeks to finish the study. Patients with OA of the knee will make up to 8 outpatient visits and will take up to 5 months to finish the study.
A pharmaceutical company (Levicept Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0306
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion