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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04207957
Eligibility Criteria:
Inclusion Criteria:
* males or females of any ethnic origin between 18 and 55 years of age
* subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.
* subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Exclusion Criteria:
* Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
* Female subjects who are pregnant or lactating.
* Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
* Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
* Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
* Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04207957
Study Brief:
Protocol Section:
NCT04207957