A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
Completed · Phase 1 · Has a placebo group
Conditions studied: Asthma
In brief
The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.
Key facts
- Study ID
- NCT01928368
- Run by
- Amgen
- People needed
- 70
- Starts
- 2013-08-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-12-14
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- (All subjects)
- History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
- Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.
- Other criteria may apply.
Where it is running
- Research Site — Cypress, California, United States
- Research Site — Aventura, Florida, United States
- Research Site — Lenexa, Kansas, United States
- Research Site — Raleigh, North Carolina, United States
- Research Site — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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