A Phase 1 interventional study of AMG 403 and Placebo in Chronic Pain, sponsored by Amgen. Completed. Per ClinicalTrials.gov, last updated 2015-01-30.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AMG 403 administered as subcutaneous and intravenous doses
Drug: AMG 403
No active drug
Drug: Placebo
AMG 403 is for treatment of subjects with chronic pain
contains no active drug
Incidence of treatment emergent adverse events
Time frame: up to 112 days
Incidence of abnormal clinically significant vital signs
Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.
Time frame: up to 112 days
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.
Time frame: up to 112 days
Incidence of abnormal clinically significant ECG results
ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.
Time frame: up to 112 days
Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
Time frame: up to 112 days
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Amgen