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The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NI-0501 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NI-0501 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of escalating single IV doses of NI-0501. | AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501 | PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Warrington, MD | HMR | Principal Investigator |
| Peter Dewland, MD | ICON plc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMR | London | United Kingdom | ||||
| ICON |
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| ID | Term |
|---|---|
| C000644327 | Emapalumab |
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|
| Manchester |
| United Kingdom |