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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT06886659
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male participant, age 18 to 55 years old
* BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
* Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
* Able to understand procedure, agree to participate and willing to give informed consent.
* Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
* Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.
Exclusion Criteria:
* Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)\]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
* History of and/or current cardiac disease
* Neutrophil count less than the lower limit of normal range during screening.
* A positive hepatitis screen (includes subtypes B \& C).
* Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
* History of any cancer, including carcinoma in situ
* Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
* Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
* History or evidence of drug abuse or of alcoholism or of moderate alcohol use.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06886659
Study Brief:
Protocol Section:
NCT06886659