To investigate the safety and tolerability of the intravenously applied (directly given into a blood vessel) new test compound.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the safety and tolerability of the intravenously applied
(directly given into a blood vessel) new test compound.
Secondary outcome
- To study how the test compound is absorbed, broken-down and excreted by the
body.
- To study the effect of new test compound on the body.
Background summary
The test compound is a drug that is being developed for the treatment of
anthrax.
Study objective
To investigate the safety and tolerability of the intravenously applied
(directly given into a blood vessel) new test compound.
Study design
Phase 1, randomized, placebo controlled, double blind, single dose-escalation
study.
Intervention
36 healthy male and female volunteers will participate in the trial. 32 men and
women will receive an infusion once of 0.5, 1, 2.5 or 7.5 test compound per
kilo body weight or placebo.
Study burden and risks
The test medication has not been previously tested in humans but was
extensively tested in animals. In these animal models multiple dosing were
given and no side effects were seen. However unknown side effects or allergic
reactions can never be excluded.
The dose levels are selected on the basis of research results in animals and
humans. The risk to health at these dose levels is limited but you may
experience one of the above mentioned side-effects or other symptoms not
previously reported. Your health will be closely monitored during the trial to
minimize these risks.
Rozenburglaan 13a
9727 DL Groningen
NL
Rozenburglaan 13a
9727 DL Groningen
NL
Listed location countries
Age
Inclusion criteria
Male and female subjects, aged between 18 and 55, BMI 18 to 30 kg/m2
Exclusion criteria
Clinical significant abnormalities during 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 | EUCTR2010-023581-42-NL |
CCMO | NL34458.056.10 |