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Study Complete
Sponsor ID
20040147

A study to examine the safety, pharmacokinetics and pharmacodynamics of single dose of AMG 623 in subjects with systemic lupus erythematosus

Sponsor ID
20040147
Clinicaltrials.gov ID
NCT02443506
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 623
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
56
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment emergent adverse events

Timeframe: up to 70 days

Incidence of abnormal clinically significant vitl signs

Timeframe: up to 70 days

Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

Timeframe: up to 70 days

Incidence of abnormal clinically significant ECG results

Timeframe: up to 70 days

Secondary Outcome Measures

Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax

Timeframe: up to 70 days

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
N/A
Condition
  • Lupus
    • Sex
    N/A
    Trial Dates
    Oct 2004 - Apr 2007
    Inclusion and Exclusion Criteria
    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