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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 403 | Experimental | AMG 403 administered as subcutaneous and intravenous doses |
|
| Placebo | Placebo Comparator | No active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 403 | Drug | AMG 403 is for treatment of subjects with chronic pain |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | 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. | 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. | 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. | up to 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax | up to 112 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26449617 | Derived | Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000609797 | AMG 403 |
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| Placebo |
| Drug |
contains no active drug |
|