A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject
NCT ID: NCT02348879
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2005-01-31
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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AMG 403
AMG 403 administered as subcutaneous and intravenous doses
AMG 403
AMG 403 is for treatment of subjects with chronic pain
Placebo
No active drug
Placebo
contains no active drug
Interventions
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AMG 403
AMG 403 is for treatment of subjects with chronic pain
Placebo
contains no active drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20040195
Identifier Type: -
Identifier Source: org_study_id