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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02443506

Enrollment

Registered

2015-05-14

Start date

2004-10-31

Completion date

2007-06-30

Last updated

2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

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.

Interventions

DRUGAMG 623

Single dose of AMG 623 administered as subcutaneous and intravenous doses

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax	up to 70 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026