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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-0701 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NI-0701 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers |
| Measure | Description | Time Frame |
|---|---|---|
| NI-0701 Pharmacokinetic parameters in healthy volunteers | ||
| NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion | ||
| Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lambert, MD | PXL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | United Kingdom |
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|
| Immunogenicity of NI-0701 |