To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability of escalating single IV doses of NI-0801.
Secondary outcome
Pharmacokinetics and pharmacodynamics parameters of escalating single IV doses
of NI-0801.
Background summary
Plasma and/or local IP-10 levels are upregulated in multiple autoimmune
disorders and inflammatory diseases. NI-0801 is a fully human antibody capable
of neutralizing human IP-10 with high affinity.
Study objective
To assess the safety and tolerability of escalating single IV doses of NI-0801.
To determine the pharmacokinetics and pharmacodynamics parameters of escalating
single IV doses of NI-0801.
Study design
Randomized, double-masked, placebo-controlled, dose escalation.
Intervention
Not applicable
Study burden and risks
The risks during this trial are the possible side effects related to the study
medication.
Also the admission period, venapunctures and placing of the canula may cause a
burden to the volunteers.
For each dose, two volunteers wil be dosed and only if there are no safety
concerns, the following four volunteers wil be dosed. All volunteers are being
monitored by experienced physicians and study personell.
14 Chemin des Aulx
1228 Plan les Ouates
Switzerland
14 Chemin des Aulx
1228 Plan les Ouates
Switzerland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-003243-36-NL |
| CCMO | NL23900.040.08 |