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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03585803
Eligibility Criteria:
Inclusion Criteria:
* A male whose age is between 19 and 55 years of age
* A person whose body mass index is between 18.5 and 27 kg/m2 at screening
* A person who has the ability and willingness to participate in the clinical trial
* A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial
Exclusion Criteria:
* A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology\*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
* A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
* A person with infectious disease or severe trauma within 21 days of the randomization date
* A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
* A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening
* A person with a glomerular filtration rate less than 60 mL/min/1.73 m2 calculated from serum creatinine at screening
* A person with a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 60 mmHg, or greater than 100 mmHg at screening
* A person with thrombocytopenia or coagulopathy which should not be given intramuscular injection
* A person whose weekly average drinking amount exceeds 140g of alcohol per week
* A person whose daily average smoking amount exceeds 10 per day
* A person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection
* A person who has the history of substance abuse or positive urine screening test
* A person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization
* A person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days
* A person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm
* A person who has clinically significant abnormalities from clinical laboratory test
* A person who is deemed ineligible for clinical trials by the investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03585803
Study Brief:
Protocol Section:
NCT03585803