To evaluate the safety and tolerability of DC-TAB following a single dose and following repeated dosing in healthy volunteers. To assess the pharmacokinetics of DC-TAB following a single dose and following repeated dosing in healthy volunteers. To…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of DC-TAB following a single dose and
following repeated dosing in healthy volunteers.
Secondary outcome
To assess the pharmacokinetics of DC-TAB following a single dose and following
repeated dosing in healthy volunteers.
To evaluate the T-cell tolerizing effect of DC-TAB in healthy volunteers. To
evaluate levels of DC-TAB specific and -neutralizing antibodies.
Background summary
DC-TAB is recombinant protein resembling a substance which normally exists in
the human body: the alpha B-crystalline (cryab). This substance protects normal
cells in the nervous system. In humans, a natural response is present against
cryab. This response is to powerful in patients with MS and causes
inflammations of the nervous system and causes the symptoms of MS. By treating
subjects with DC-TAB, the immune system will tolerate this substance (cryab)
and will possibly reduce the inflammations causing MS and the symptoms of MS
may diminish or stabilize.
Study objective
To evaluate the safety and tolerability of DC-TAB following a single dose and
following repeated dosing in healthy volunteers. To assess the pharmacokinetics
of DC-TAB following a single dose and following repeated dosing in healthy
volunteers. To evaluate the T-cell tolerizing effect of DC-TAB in healthy
volunteers. To evaluate levels of DC-TAB specific and -neutralizing antibodies.
Study design
A double-blind and randomized, study.
Intervention
The study consists of 2 parts. In Part 1, all subjects will receive a single
dose of study medication on day 1; in Part 2, different subjects will receive
medication once daily during 3 consecutive days.
In Part 1, four groups of subjects (n=10) will be studied in a dose-escalation
design. Each group of subjects will be randomized to receive either DC-TAB
(n=8) or placebo (n=2) once.
In Part 2, three groups of subjects (n=12) will be studied in a dose-escalation
design. Each group of subjects will be randomized to receive either DC-TAB
(n=9) or placebo (n=3) once daily on 3 consecutive days.
Study burden and risks
The risks associated with this investigation are linked together with the
possible side effects of the dosing via a bolus injection and the
investigational product (e.g. allergic reaction). The burden on the volunteer
consists of a confinement during recording periods, venapunctures and the
introduction of the cannulas. All volunteers are closely monitored and
supervised by experienced doctors and study staff for possible side effects and
adverse reactions.
Zernikedreef 9
2333 CK Leiden
NL
Zernikedreef 9
2333 CK Leiden
NL
Listed location countries
Age
Inclusion criteria
• you have given your written consent to take part in this study;
• you are between 18 and 55 years of age (inclusive);
• you are in good physical and mental health;
• your body weight must be appropriate in relation to your height;
•The use of suitable anti conception in the 3 months before start of the study and you will remain using this until 3 months after the study and/or you can not invoke an pregnancy (males) or you can not get pregnant (females)
• no abnormalities are diagnosed during the screening.
Exclusion criteria
•If you are pregnant, planning to get pregnant or breastfeeding;
•If you have relatives (1st degree) who have MS;
•If you smoke 5 or more cigarettes per day or are not able to stop smoking during the admission period;
•If you have abused drug (past and present) and or alcohol
•The use of prescribed medication in the 14 days before start of the study, except for hormone based anticonceptionals, standard vitamines and paracetamol;
•If you recieved a vaccination within the 4 weeks before the start of the study;
•you have taken part in another clinical drug study during the last 3 months prior to the study;
• you have donated blood in the three months before admission;
•you have donated plasma in the 7 days before admission;
•if you have recieved bloodproducts in the 6 month before start of start of the study;
• you are Hepatitis B, C or HIV positive;
If no immune response can be achieved by DC-TAB in your blood;
•you are not suitable to participate in this study according to the investigator.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016817-68-NL |
| CCMO | NL30321.040.09 |