No registrations found.
ID
Source
Health condition
IQNLF is a human antibody which can help in overcoming inhalation antrhax. Anthrax is caused by exposure to Bacillus anthracis, a spore forming bacterium. The infection can be lethal, especially when the spores are inhaled.
Sponsors and support
Rozenburglaan 13a
9727 DL Groningen
The Netherlands
Rozenburglaan 13a
9727 DL Groningen
The Netherlands
Intervention
Outcome measures
Primary outcome
Safety and tolerability of intravenous administered IQNLF in healthy subjects.
Secondary outcome
Pharmacokinetics, pharmacodynamics and immunogenticity of intravenous administered IQNLF in healthy subjects.
Background summary
The study evaluates the safety and kinetics of a human antibody against anthrax. The results will help in further development of a life-saving drugs against inhalation anthrax infections.
Study objective
Determine safety and kinetics of IQNLF in humans.
Study design
Volunteers will be tested periodically during a period of 90 days after receiving a single dosis. Testing occurs during the first 24 hours and after day 7, 14, 28, 42, 56 and 91 days.
Testing involves vital signs and laboratory parameters.
Pharmacokinetic and immunogenicity parameters will be tested as well.
Intervention
The effect of IQNLF will be compared with placebo control. Treatment involves a single i.v. administration.
Rozenburglaan 13a
Hans Hektor
Groningen 9727 DL
The Netherlands
h.hektor@iqtherapeutics.nl
Rozenburglaan 13a
Hans Hektor
Groningen 9727 DL
The Netherlands
h.hektor@iqtherapeutics.nl
Inclusion criteria
1. Male or female subjects;
2. Aged between 18 and 55;
3. No active, significant, acute or chronic illness.
Exclusion criteria
1. History of any (investigational) anthrax therapy;
2. Excessive alcohol consumption;
3. Known hypersensitivity to excipients;
4. Smoking more than 10 cigarettes or equivalent per day.
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 |
|---|---|
| NTR-new | NL2628 |
| NTR-old | NTR2756 |
| Other | IQ Therapeutics : TCL10-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |