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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05200169
Eligibility Criteria:
Inclusion Criteria Included:
* Healthy Male as determined by a physician, based on a medical evaluation including medical history, physical examination, clinical laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Sponsor Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Male between 18 and 65 years old inclusive, at the time of signing the informed consent.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive at screening
* Body weight between 60 and 90 kg
* Normal blood pressure and heart rate or, if abnormal, considered not clinically significant by the principal Investigator or sub-investigator.
* Neutrophils count should be within normal range or deemed as not clinically significant by the PI
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
Exclusion Criteria Included:
* Any clinically significant cardio vascular diseases such as but not limited to the common reported below:
* History or presence or suspect of Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery bypass graft surgery or stent procedure;
* History or presence or suspect of Angina Pectoris;
* History or presence or suspect, heart failure;
* Abnormal vital signs
* Clinically significant abnormal Blood Pressure according to investigator's opinion
* Abnormal resting ECG according investigator's opinion.
* Clinically significant, abnormal medical history, physical findings, ECG, or laboratory values at the screening visit that could interfere with the objectives of the study or the safety of the volunteer.
* A history of clinically significant acute illness (resolved within 4 weeks of screening), or history of significant cardiac arrhythmias or unexplained syncope or presence of cardiovascular, gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, pulmonary, immunologic, dermatologic or psychiatric disease or any other condition which, in the opinion of the Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
* Subject has an uncontrolled intercurrent illness (i.e., active infection) or fever (oral temperature \> 38 degrees Celsius) at screening.
* Clinically significant history of or current seizure disorder or history of syncope, unexplained loss of consciousness or clinically significant history of Central Nervous System (CNS) disorders
* Failure to satisfy the investigator of fitness to participate for any other reason
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05200169
Study Brief:
Protocol Section:
NCT05200169