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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT06127368
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit
* Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m²
* Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination
* Subject who has been deemed suitable based on screening test results assessed by the principal investigator
* Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures
Exclusion Criteria:
* Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.
* Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.
* Rhabdomyolysis
* Seizure, Epilepsy, Fainting
* peptic ulcer or gastrointestinal hemorrhage
* Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion
* Severe physical/organ abnormalities
* Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus
* Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.
* Medications, including antidepressants, that can induce Rhabdomyolysis
* Medications with a risk of ulcer development.
* Potent inhibitors of cytochrome P450 (CYP) enzymes
* Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors
* Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access
* Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT06127368
Study Brief:
Protocol Section:
NCT06127368