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
About this trial
This is an interventional treatment trial for Chronic Pain
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.
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
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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