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This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.
AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK001 | Experimental | Up to six single ascending doses of AK001. |
|
| Saline Solution | Placebo Comparator | Saline solution will be administered as a single infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK001 | Drug | Given parenterally. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively | Within 86 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate hypersensitivity skin testing | Within 28 days | |
| Peripheral blood counts for eosinophils and basophils | Within 28 days | |
| Serum eosinophilic cationic protein (ECP) and tryptase levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Allakos Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
|
| Within 28 days |
| 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2 | Within 28 days |