Single Ascending Intravenous Infusion Study in Healthy Subjects
Research type
Research Study
Full title
A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT BLIND, SINGLE ASCENDING DOSE, PLACEBO CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO6926496 FOLLOWING INTRAVENOUS INFUSION IN HEALTHY SUBJECTS
IRAS ID
164505
Contact name
Jim Bush
Contact email
Sponsor organisation
Hoffman La Roche
Eudract number
2014-003170-16
Duration of Study in the UK
0 years, 9 months, 23 days
Research summary
The study drug is being investigated as a possible treatment for Alzheimer's Disease (AD) in the future.
This Study is the first time that the Study Drug is being given to humans. It has been tested extensively in animals at doses higher than the highest dose planned for this Study.
This Study uses a placebo control (‘dummy’ medication); some participants will receive the Study Drug and some will receive placebo as an injection through veins. Which participants receive Study Drug or placebo will be determined randomly. Also, this is a double blind study; which means volunteer and the investigator will not know who had the study drug or placebo.
48 healthy male volunteers in 6 groups are planned to be enrolled into this study. There will be 6 volunteers on study drug and 2 volunteers on placebo. Each volunteer will receive a single dose of study drug or placebo. The intention is to dose 8 volunteers in each group, (6 volunteers on study drug and 2 volunteers on placebo) with 2 volunteers in each group being dosed 24 hours prior to the rest of the group (one study drug and one placebo ).
The starting dose level of Study Drug will be 30 mg and it is planned to continue dosing up to a maximum dose level of 2800mg. The total duration of the study for each healthy volunteer will be up to 16 weeks.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1828
Date of REC Opinion
2 Dec 2014
REC opinion
Further Information Favourable Opinion