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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT06125366
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to any study specific tests or procedures
* Ability and willingness to understand and follow study-related instructions
* Subject is healthy as determined by the investigator
* Japanese male
* Age 20 to 40 years (inclusive) at screening visit
* Body mass index (BMI): 18.0 to 28.0 kg/m\^2(inclusive)
* Body weight: at least 50 kg (inclusive)
* Subjects of reproductive potential must agree to use condoms whenever having sexual intercourse with a woman of child-bearing potential. This applies to the time period from signing of the ICF to at least 1 week after treatment.
Exclusion Criteria:
* Current smoker, or has smoked within 3 months prior to screening Clinical Study Protocol
* Any severe disease within the last 4 weeks prior to administration of study drug
* History of orthostatic hypotension, fainting spells and blackouts
* Any malignant tumor and history thereof
* Any clinically relevant finding at the physical examination
* Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any contrast agent
* Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the Upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
* Clinically relevant ECG findings, e.g.: Heart rate \<45 or \> 90 beats/min, PR \>220 msec, QTcF \>450 msec, QRS \>120 msec, branch bundle block, any sign of coronary heart disease at screening
-. Abnormal vital signs, e.g.: Systolic blood pressure \<90 or \>140 mmHg, Diastolic blood pressure \<45 or \>90 mmHg at screening
* Subjects who have participated in a clinical study of an investigational drug within 4 months or an approved drug within 3 months prior to administration of study drug
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT06125366
Study Brief:
Protocol Section:
NCT06125366