A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject

Study Overview
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Brief Summary
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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.

Official Title
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A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: AMG 403
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women of non-child bearing potential, Between the ages of 18 and 55 inclusive, Body mass index from 18 to 33 kg/m2, Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct. Exclusion Criteria: Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia, Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system, History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 403<br>AMG 403 administered as subcutaneous and intravenous doses | Drug: AMG 403<br>* AMG 403 is for treatment of subjects with chronic pain<br>|
| Placebo Comparator: Placebo<br>No active drug | Drug: Placebo<br>* contains no active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax |  | up to 112 days |