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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT05018403
Eligibility Criteria:
Inclusion Criteria:
* 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Body mass index (BMI) within the range 18 - 30 kg/m2 with a body weight between 50 kg and 120 kg.
* Male subjects
* Subject is healthy as determined by medical evaluation
* Subject provided written informed consent
* Subject is willing to comply with all requirements and restrictions according to the study protocol.
Exclusion Criteria:
* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
* Any acquired or congenital immune deficiency.
* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
* Any concomitant disease, condition, or treatment that could interfere with the conduct of the study.
* Any acquired or congenital immune deficiency.
* Acute infection (including viral infections) in the preceding 6 weeks (8 weeks for respiratory infections).
* Clinically relevant abnormality following the Investigator's review of the physical examination, vital signs, ECG and clinical study protocol-defined clinical laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the trial at screening and admission.
* Evidence of COVID-19 signs or symptoms, exposure to infected person or confirmed COVID-19 infection within the last 2 weeks.
* Use of any concomitant medication or prescribed or non-prescribed drugs within 2 weeks or 5 times the half-life, whichever is longer, prior to the first study treatment administration.
* Administration of vaccine(s) within 2 weeks prior to screening or plans to receive such vaccines during the study.
* Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times, whichever is longer, prior to dosing.
* Positive drug or alcohol screen at screening and admission.
* Any significant blood loss, donated one unit (450 mL) of blood or more, or donated plasma, or received a transfusion of any blood or blood products within 30 days prior to dosing.
* Subjects who are unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice and /or pomelos, exotic citrus fruits, grapefruit hybrids, starfruit or fruit juices from 72 hours prior to dosing on Day 1, until completion of the last pharmacokinetic (PK) blood sample time point.
* Legal incapacity or limited legal capacity, or incarceration.
* Inability to understand or communicate reliably with the Investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05018403
Study Brief:
Protocol Section:
NCT05018403