Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT01928368
Eligibility Criteria:
Inclusion Criteria (All subjects)
* Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
* Females must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy).
* Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only)
* Documented history of mild, stable atopic asthma within 2 years of screening.
* Has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) \> 70% predicted at screening.
Exclusion Criteria
(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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01928368
Study Brief:
Protocol Section:
NCT01928368