At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
AMG 570 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating AMG 570 and AMG 570 Matching Placebo for Systemic Lupus Erythematosus. Completed, enrolled 56 participants across 3 sites.
Detailed Summary
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartMar 2016
Primary CompletionSep 2018
Study CompletionDec 2018
TodayJul 2026
First PostedDec 2, 2015
Enrollment StartMar 28, 2016
Primary CompletionSep 6, 2018
Study CompletionDec 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.6 years ago
Interventions
AMG 570biological
7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
AMG 570 Matching Placebobiological
Placebo administered as single dose subcutaneous in healthy volunteers.