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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: AMG 403; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 20040195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No