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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 403
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AMG 403

    Placebo

    Arm Description

    AMG 403 administered as subcutaneous and intravenous doses

    No active drug

    Outcomes

    Primary Outcome Measures

    Incidence of treatment emergent adverse events
    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.
    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.
    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.

    Secondary Outcome Measures

    Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    January 28, 2015
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02348879
    Brief Title
    A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 403
    Arm Type
    Experimental
    Arm Description
    AMG 403 administered as subcutaneous and intravenous doses
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    No active drug
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 403
    Intervention Description
    AMG 403 is for treatment of subjects with chronic pain
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    contains no active drug
    Primary Outcome Measure Information:
    Title
    Incidence of treatment emergent adverse events
    Time Frame
    up to 112 days
    Title
    Incidence of abnormal clinically significant vital signs
    Description
    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
    Title
    Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
    Description
    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
    Title
    Incidence of abnormal clinically significant ECG results
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
    Time Frame
    up to 112 days

    10. Eligibility

    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26449617
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

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

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