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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07450833
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent form.
* Subjects capable to understand the purposes and risks of the study.
* Male volunteers willing to comply with contraception requirements.
* Aged 18-60 years, inclusive.
* Healthy participants, as determined by screening assessments and Principal Investigator's judgment (absence of active/chronic disease).
* Body Mass Index (BMI) of 18-30 kg/m² inclusive.
* Male participants with female partners of childbearing potential must agree to be abstinent or use a male condom plus partner use of a contraceptive method.
Exclusion Criteria:
* Clinically relevant history of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, or connective tissue disorders.
* Fridericia's correction factor for QT (QTcF) \> 450 ms or history of QT interval prolongation.
* Acute gastrointestinal symptoms at screening/admission.
* Any abnormal laboratory value of Grade 2 or higher considered clinically significant.
* Values ≥ 10% above upper limit of normal for ALT, AST, Alkaline Phosphatase, Creatinine, or Urea.
* Clinically relevant surgical history.
* History of relevant drug hypersensitivity, alcoholism, or drug abuse.
* Significant infection or known inflammatory process.
* Use of prescription/non-prescription medicines within 2 weeks of admission.
* Receipt of investigational drug within 30 days prior to screening.
* Use of tobacco/nicotine products within 3 months of screening.
* Positive alcohol or drug screen.
* Blood donation within 3 months prior to screening.
* Vaccinated with a Covid-19 vaccine within 2 weeks prior to screening.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07450833
Study Brief:
Protocol Section:
NCT07450833