A study to investigate the effect of Clozapine in healthy volunteers
Research type
Research Study
Full title
A Phase I Study Evaluating the Effect of Clozapine on B Cell Number and Function in Healthy Volunteers
IRAS ID
271495
Contact name
Annelize Koch
Contact email
Sponsor organisation
Zarodex Pharmaceuticals
Eudract number
2019-003402-27
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
The purpose of this study is to assess how the administration of different doses of clozapine affects the function and number of a certain type of cell in the immune system (B cells) over a period of 41 days.
During the study, there will be 2 treatment groups; the active group and the control group. The active group will be given the study drug clozapine at different doses ranging from single doses of 12.5 milligrams (mg) up to 100 mg twice a day for a period of 41 days. The control group will not be given the active drug but will be monitored for the same period of time as the active group. However on Day 1 of the study, both groups will be given a vaccination called Typhim Vi which is a vaccine for protection against typhoid fever.
The purpose of this is to stimulate a quick immune response in the body and compare how the number and function of the immune cells (particularly B cells) produced differs between the active and the control group.
By comparing this, the study sponsor may be able to determine as to whether administering clozapine at lower doses than those used for standard of care in schizophrenia has an effect on these cells which could be used positively in patients with autoimmune diseases by lowering the production of B cells, therefore alleviating and managing symptoms more effectively.
This study will be conducted in 24 healthy volunteers (12 in each arm); both males and females of child bearing potential.
REC name
Wales REC 2
REC reference
19/WA/0247
Date of REC Opinion
19 Sep 2019
REC opinion
Further Information Favourable Opinion