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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01423318
Eligibility Criteria:
Inclusion Criteria:
* Adult healthy males and females, 18 to 55 years of age inclusive
* Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation
* Body weight between 45 and 105 kg, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations
* Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion
* Negative for hepatitis B, hepatitis C, and HIV infection
* Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol)
Exclusion Criteria:
* Pregnant and lactating women
* History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components
* History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure
* Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study
* Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine \>500 ng/mL. Minimal/intermittent smoking will be permitted during the study
* Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1)
* History of significant, chronic, or recurrent infections requiring treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01423318
Study Brief:
Protocol Section:
NCT01423318