Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Part 1: single ascending doses (SAD) in up to 11 SAD cohorts plus a Japanese cohort Part 2: multiple doses (MD) up to 6 MD cohorts

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ELA026 Following Intravenous and/or Subcutaneous Administration of Single and Multiple Doses in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ELA026
* Drug: ELA026


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age. Must be in good general health. No clinically significant abnormal laboratory values during screening. Body mass index of 18 - 32 kg/m2. Exclusion Criteria: Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening. Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed). Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results. Active or latent tuberculosis (TB), regardless of treatment history, Positive drug abuse test. Positive HIV, HBV, HCV test results. Clinically significant ECG test results. Clinically significant vital sign results.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Single Ascending Dose<br>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 | Drug: ELA026<br>* Single dose of ELA026<br>|
| Experimental: Part 2: Multiple Ascending Dose<br>Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined | Drug: ELA026<br>* Multiple doses of ELA026<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]. |  | By week 3 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |