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.
Completed
- Conditions
- psoriasis10003816
- Registration Number
- NL-OMON33532
- Lead Sponsor
- ovImmune S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
• written consent • men between 18 and 50 years old • physically en mentally healthy • normal BMI
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability of escalating single IV doses of NI-0801.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics and pharmacodynamics parameters of escalating single IV doses<br /><br>of NI-0801.</p><br>