A randomized, double-blinded, placebo-controlled, single centre, phase I study of the safety of escalating single intravenous doses of NI-0801 in healthy volunteers.

A randomized, double-blinded, placebo-controlled, single centre, phase I study of the safety of escalating single intravenous doses of NI-0801 in healthy volunteers. - Phase I study to investigate the safety of escalating i.v. doses of Ni-0801

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33532

Enrollment

Registered

2008-07-07

Start date

2008-08-05

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

psoriasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • written consent • men between 18 and 50 years old • physically en mentally healthy • normal BMI

Exclusion criteria

Exclusion criteria: • smoking • drugs and/or alcohol abuse • surgery within 3 months prior to study • use concomitant medication in two weeks prior to study • participation in another clinical study in 3 months prior to this study • Blood donation in 3 months prior to this study • positive for Hepatitis B, C or HIV • positive tuberculosis test • Vaccination within 6 weeks prior to start study medication

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of escalating single IV doses of NI-0801.	—

Secondary

Measure	Time frame
Pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.	—

Countries

Netherlands

Outcome results