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Assessment of the safety and kinetics of IQNLF.


- candidate number9119
- NTR NumberNTR2756
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2011
- Secondary IDsTCL10-01 IQ Therapeutics
- Public TitleAssessment of the safety and kinetics of IQNLF.
- Scientific TitlePhase I, randomized, placebo controlled, double blind, single dose-escalating study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.
- ACRONYM
- hypothesisDetermine safety and kinetics of IQNLF in humans.
- Healt Condition(s) or Problem(s) studiedAnthrax, IQNLF, Human antibody
- Inclusion criteria1. Male or female subjects;
2. Aged between 18 and 55;
3. No active, significant, acute or chronic illness.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-feb-2011
- planned closingdate10-jul-2011
- Target number of participants32
- InterventionsThe effect of IQNLF will be compared with placebo control. Treatment involves a single i.v. administration.
- Primary outcomeSafety and tolerability of intravenous administered IQNLF in healthy subjects.
- Secondary outcomePharmacokinetics, pharmacodynamics and immunogenticity of intravenous administered IQNLF in healthy subjects.
- TimepointsVolunteers 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Hans Hektor
- CONTACT for SCIENTIFIC QUERIES Hans Hektor
- Sponsor/Initiator IQ Therapeutics
- Funding
(Source(s) of Monetary or Material Support)
IQ Therapeutics
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD16-feb-2011 - 24-feb-2011


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