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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01844804
Eligibility Criteria:
Inclusion Criteria:
* Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \>50kg (110 lbs).
Exclusion Criteria:
* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Previous exposure to a monoclonal antibody, or current use of other biologics.
* History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
* History of tuberculosis (TB) or a positive latent TB test at Screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01844804
Study Brief:
Protocol Section:
NCT01844804