Phase 1, randomized, placebo controlled, double blind, single dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.

Phase 1, randomized, placebo controlled, double blind, single dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects. - IQNLF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36585

Enrollment

Registered

2010-12-02

Start date

2011-02-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Anthrax Bacillus anthracis

Interventions

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.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female subjects, aged between 18 and 55, BMI 18 to 30 kg/m2

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities during medical research

Design outcomes

Primary

Measure	Time frame
To investigate the safety and tolerability of the intravenously applied (directly given into a blood vessel) new test compound.	—

Secondary

Measure	Time frame
- 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)