A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject
CompletedPhase 1NCT02348879
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Interventions
- Drug: AMG 403
- Drug: Placebo
- Sponsor
- Amgen
- Start date
- 2005-01
- Primary completion
- 2006-01
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02348879