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The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NI-0101 | Experimental | NI-0101 is an anti-Toll-like receptor monoclonal antibody. |
|
| Placebo | Placebo Comparator | The placebo to be used for the proposed clinical trial is a sterile solution for intravenous infusion. The placebo is identical to the NI-0101 drug product but does not include the active substance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monoclonal antibody | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of NI-0101 in healthy male/female subjects |
during 8 weeks post administration. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of NI-0101 | Blood samples for plasma NI-0101 concentrations. The following pharmacokinetic parameters of NI-0101 will be measured: Area under the curve from the time of dosing extrapolated to infinity (AUCinf); Area under curve from the time of dosing to the last measurable concentration (AUClast); AUCinf - AUClast expressed in % of AUCinf (% AUCextr); Systemic drug clearance (CL); Mean residence time (MRT) extrapolated to infinity (MRTinf); Mean residence time (MRT) at last measurable concentration (MRTlast). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Koos Prof. Burggraaf, MD, Ph | Centre for Human Drug Research, Leiden, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
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| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
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| Up to 8 weeks |
| Pharmacodynamic parameters of NI-0101 | Blood samples for inflammatory markers measured in blood with or without the presence of an exogenous stimulus (lipopolysaccharide). Cytokine levels induced by ex vivo lipopolysaccharide challenge and circulating cytokine levels induced by in vivo lipopolysaccharide challenge will be measured. | Up to 8 weeks |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |