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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT03445169
Eligibility Criteria:
Inclusion Criteria:
* Female or vasectomized male;
* If of childbearing potential, willing to practice methods of birth control;
* If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
* Has a body mass index (BMI) between 19 and 32 kg/m2; Willing and able to give written informed consent for study participation and provide consent for access to medical data;
* Willing and able to cooperate with all aspects of the protocol.
Exclusion Criteria:
* Any vaccination within 30 days before start of this study and throughout the study;
* Abnormal blood pressure or pulse rate;
* Abnormal screening electrocardiogram (ECG);
* Receipt of any investigational agent within 30 days;
* A positive history of drug abuse or a positive test result for drug(s) of abuse;
* Female subjects who are planning a pregnancy or are pregnant or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03445169
Study Brief:
Protocol Section:
NCT03445169