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ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.
This is a multi-center, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, and PD of ELA026 following single and multiple IV and/or SC dose administration in healthy adult volunteers, including a subgroup of Japanese volunteers.
The study will consist of 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose | Experimental | Cohort 1 Single dose: 0.001 mg/kg IV Cohorts 2 - 11 Single dose: dose level and route (IV or SC) to be determined Japanese Cohort Single dose: dose level and route (IV or SC) to be determined |
|
| Part 2: Multiple Ascending Dose | Experimental | Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELA026 | Drug | Single dose of ELA026 |
| |
| ELA026 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]. | By week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of ELA026 | By week 3 | |
| Change from baseline of monocytes levels. | By week 3 | |
| Change from baseline of lymphocytes levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States | ||
| Medical University of Vienna |
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| Drug |
Multiple doses of ELA026 |
|
| By week 3 |
| Presence of Anti-drug antibodies to ELA026 | By week 3 |
| Comparison of ELA026 Maximum observed drug concentration (Cmax) | By week 3 |
| Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC) | By week 3 |
| Vienna |
| Austria |