A SAD/MAD study of BN201 in healthy volunteers
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of BN201 in healthy subjects
IRAS ID
229047
Contact name
Annelize Koch
Contact email
Sponsor organisation
Bionure Farma S.L.
Eudract number
2017-001202-14
Duration of Study in the UK
0 years, 6 months, 9 days
Research summary
This is a two-part study assessing a new drug called BN201, when given as a single dose or as multiple doses.
The drug (BN201) has not yet been given to humans, so this will be a first in human study. The drug is designed to treat acute optic neuritis, which is caused by inflammation to the optic nerve and leads to vision loss.
Part A of the study will be made up of 4 cohorts of 8 subjects. Subjects will attend Simbec for two treatment periods. At the second treatment period the dose will be higher than the 1st dose they received. Before increasing the dose, we will review all the collected data to ensure its safe.
Following completion of Part A, all the data will reviewed and a dose for Part B will be decided. Part B will involve the drug being administered on 5 consecutive days. Part B will involve 2 cohorts of 8 subjects.
We will assess the way the body handles the drug and also look at the effect the drug has on your body. In order to do this we will take blood samples at pre-determined time points.
REC name
Wales REC 1
REC reference
17/WA/0196
Date of REC Opinion
25 Jul 2017
REC opinion
Further Information Favourable Opinion