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

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Placebo; Drug: AMG 403

• Registration Number: NCT02348879
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-01
• Study Completion: 2006-03
• Study First Submitted: 2014-12-23
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 51

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	No active drug
AMG 403	AMG 403	AMG 403 administered as subcutaneous and intravenous doses

Primary Outcome Measures

Name	Time	Method
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results	up to 112 days	Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.
Incidence of abnormal clinically significant vital signs	up to 112 days	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.
Incidence of abnormal clinically significant ECG results	up to 112 days	ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.
Incidence of treatment emergent adverse events	up to 112 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax	up to 112 days