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NCT00818948 · ClinicalTrials.gov registry record · Phase 1
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00818948 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 56 participants.
The verdict
NCT00818948, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.
Interventions
- DRUG AMG 811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00818948
The ClinicalTrials.gov registry entry for NCT00818948 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AMG 811 is the first listed.
NCT00818948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00818948 about?
NCT00818948 is a clinical study titled "Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis". This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will...
What is the current status of trial NCT00818948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2009-03. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00818948?
The interventions under investigation include: AMG 811 (DRUG).
Who is sponsoring clinical trial NCT00818948?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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