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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT02953132
Eligibility Criteria:
Inclusion Criteria:
* Healthy and free from clinically significant illness or disease
* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
* A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2
Exclusion Criteria:
* Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02953132
Study Brief:
Protocol Section:
NCT02953132