A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Official Title
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A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: AMG 623
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, between the ages of 18 and 55 Diagnosis of SLE Have had a disease duration of at least 1 year, as diagnosed by a physician Exclusion Criteria: Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 623<br>Single dose of AMG 623 administered as subcutaneous and intravenous doses | Drug: AMG 623<br>* Single dose of AMG 623 administered as subcutaneous and intravenous doses<br>|
| Placebo Comparator: Placebo<br>Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses | Drug: Placebo<br>* Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events |  | up to 70 days | 
| Incidence of abnormal clinically significant vital signs |  | up to 70 days | 
| Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results |  | up to 70 days | 
| Incidence of abnormal clinically significant ECG results |  | up to 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax |  | up to 70 days |