Assessment of the safety and kinetics of IQNLF.

Phase I, randomized, placebo controlled, double blind, single dose-escalating study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20298

Enrollment

Registered

2011-02-16

Start date

2011-02-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

The effect of IQNLF will be compared with placebo control. Treatment involves a single i.v. administration.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects; 2. Aged between 18 and 55; 3. No active, significant, acute or chronic illness.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Safety and tolerability of intravenous administered IQNLF in healthy subjects.	—

Secondary

Measure	Time frame
Pharmacokinetics, pharmacodynamics and immunogenticity of intravenous administered IQNLF in healthy subjects.	—

Contacts

Public ContactHans Hektor

IQ Therapeutics Rozenburglaan 13a

h.hektor@iqtherapeutics.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)