Determine safety and kinetics of IQNLF in humans.
ID
Bron
Aandoening
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.
Ondersteuning
Rozenburglaan 13a
9727 DL Groningen
The Netherlands
Rozenburglaan 13a
9727 DL Groningen
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety and tolerability of intravenous administered IQNLF in healthy subjects.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Determine safety and kinetics of IQNLF in humans.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
The effect of IQNLF will be compared with placebo control. Treatment involves a single i.v. administration.
Publiek
Rozenburglaan 13a
Hans Hektor
Groningen 9727 DL
The Netherlands
h.hektor@iqtherapeutics.nl
Wetenschappelijk
Rozenburglaan 13a
Hans Hektor
Groningen 9727 DL
The Netherlands
h.hektor@iqtherapeutics.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Male or female subjects;
2. Aged between 18 and 55;
3. No active, significant, acute or chronic illness.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2628 |
| NTR-old | NTR2756 |
| Ander register | IQ Therapeutics : TCL10-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |