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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-06-30

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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 623

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Group Type EXPERIMENTAL

AMG 623

Intervention Type DRUG

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Placebo

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Interventions

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AMG 623

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Intervention Type DRUG

Placebo

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No