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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02673567
Eligibility Criteria:
Inclusion Criteria:
* The subject is a man or woman, 18 to 55 years of age, inclusive
* The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
* The subjects must be in a good health at screening and check-in
Additional inclusion criteria for Japanese subjects:
* Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
* Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
* Subject has been living outside of Japan for no more than 10 years
Additional inclusion criteria for Caucasian subjects:
* The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.
* Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
* The subject is a woman who is pregnant or lactating
* The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)
* The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment
* Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing
* Additional criteria apply, please contact the investigator for more information
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02673567
Study Brief:
Protocol Section:
NCT02673567