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This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| SC 0.3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 0.3 mg/kg of lirentelimab (AK002) administered subcutaneously. |
|
| SC 1 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered subcutaneously. |
|
| SC 3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered subcutaneously. |
|
| SC 5 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 5 mg/kg of lirentelimab (AK002) administered subcutaneously. |
|
| IV 1 mg/kg of lirentelimab (AK002) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lirentelimab (AK002) | Drug | Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of lirentelimab (AK002) administered subcutaneously by evaluating adverse events assessed using the CTCAE version 5 | Day 0 (baseline) to Day 85 | |
| Pharmacokinetics, including bioavailability, of lirentelimab (AK002) administered subcutaneously | Day 0 (baseline) to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics of lirentelimab (AK002) SC formulation as measured by changes in absolute peripheral blood counts of esoinophils | Day 0 (baseline) to Day 85 | |
| Bioavailability of lirentelimab (AK002) SC formulation relative to lirentelimab (AK002) IV by analyzing the area under the serum AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Rasmussen, MD, PhD | Allakos Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allakos Investigational Site | Edgewater | Florida | 32132 | United States |
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| ID | Term |
|---|---|
| C000654568 | AK002 |
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Subcutaneous cohorts will be assigned in a double-blind, randomized, placebo-controlled manner. IV cohorts will be open-label.
| Experimental |
Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered intravenously. |
|
| IV 3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously. |
|
| IV 3 mg/kg of lirentelimab (AK002) (Priming) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously from an IV bag prepared with extra volume for priming IV set. |
|
| SC 300 mg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 300 mg of lirentelimab (AK002) administered subcutaneously. |
|
| SC 450 mg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a total of 450 mg of lirentelimab (AK002), administered as two separate subcutaneous injections. |
|
| Placebo | Other | Placebo |
|
| Day 0 (baseline) to Day 85 |