The primary objective is to determine the safety and tolerability of KAND567 following oral single ascending dose (SAD) and multiple ascending doses (MAD) administration in healthy young and elderly subjects.
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The safety endpoint parameters are frequency and severity of adverse events,
vital signs, electrocardiography (ECG), safety laboratory tests and urinalysis.
Secondary outcome
The pharmacokinetic parameters.
Background summary
KAND567 is being developed for the treatment of inflammations and pain in
multiple sclerosis (MS).
Study objective
The primary objective is to determine the safety and tolerability of KAND567
following oral single ascending dose (SAD) and multiple ascending doses (MAD)
administration in healthy young and elderly subjects.
Study design
A first-in-human, single-centre, placebo-controlled, randomized, double-blind
study.
Intervention
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG,vital signs). Furthermore a blood and urine sample will be taken for
laboratory tests and an alcohol breathtest and drug screen will be done.
During the stay in the clinic the subject will receive the study medication and
on several time pointsblood will be taken and urine will be collected. The
subjects will be asked for possible side effects on regular basis. Furthermore
several safety assessments will be done frequently.
Finally, a follow-up visit will take place.
Study burden and risks
The study drug KAND567 has not been administered to humans before. KAND567 has
been administered to animals, as required by regulatory (health) authorities.
The dose has been selected based on the results of animal testing. The health
risks are limited at these dose levels, but you can possibly experience side
effects. In animals a number of side effects have been observed after
administration of KAND567. These side effects were changes in kidney function
due to reversible renal damage and changes in liver function. In addition,
decreased heart rate and decreased blood pressure occurred in animals.
The blood collection procedure is not dangerous, but may cause discomfort or
bruising. Occasionally, fainting, bleeding or an infection at the blood
sampling site can occur.
There are indications that in humans the function of the liver may temporarily
be disturbed after administration of KAND567 and that skin rashes may occur.
Banvaktsvägen 22
Solna 17148
SE
Banvaktsvägen 22
Solna 17148
SE
Listed location countries
Age
Inclusion criteria
Healthy male and female
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
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 | EUCTR2017-001457-13-NL |
| CCMO | NL61640.056.17 |