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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT02852551
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* body weight of 50 to 100 kg, inclusive
* subjects must be in good health
Exclusion Criteria:
* male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
* female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
* history of, any clinically significant major disorder
* clinically significant allergic condition
* significant history of alcoholism or drug/chemical abuse
* use of any tobacco or nicotine-containing products
* clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
* positive urine drugs of abuse screen or alcohol breath test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02852551
Study Brief:
Protocol Section:
NCT02852551