None listed
Conditions
Interventions
Drug : The study consists of 2 cohorts at doses of 2200 mg or 4400 mg, with 6 subjects in each cohort randomized to receive study drug and 3 subjects randomized to receive placebo. Cohort 1 will recei
Sponsors
ImmunoBiome
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Eligible participants are healthy adult male volunteers, aged between 19 and 50 years at the time of screening. ? Ethnic criteria (for Caucasian): Individuals with parents and grandparents of European, North American, or Middle Eastern descent, born in Europe, North America, or Western Asia, and having lived outside of these regions for less than 10 years. 2. Participants must weigh between 50.0 kg and 90.0 kg at the time of screening, with a Body Mass Index (BMI) of at least 18.0 kg/m² and less than 30.0 kg/m². ? BMI is calculated as Weight (kg) divided by Height (m) squared. 3. Participants must have regular bowel movements, classified as Bristol Stool Form Scale Type 3 to 5, occurring at least three times per week. 4. Participants must have fully comprehended the study details, voluntarily chosen to participate, and provided written consent to adhere to the study's instructions. 5. Participants must be deemed suitable for inclusion in the study by the investigator, based on physical examinations, clinical laboratory tests, questionnaires, and other relevant assessments.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria include a medical history of clinically significant conditions such as severe hepatobiliary disorders (e.g., viral hepatitis), renal disorders, neurological disorders, immune disorders, respiratory disorders, digestive disorders, endocrine disorders, hematologic disorders, tumors, cardiovascular conditions (e.g., heart failure, torsades de pointes), urinary disorders, psychiatric conditions (e.g., mood disorders, obsessive-compulsive disorder), or sexual dysfunction. 2. Participants with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, gastritis, gastroesophageal reflux disease) or surgery (except for simple appendectomy or hernia surgery) that may affect the safety assessment of the investigational drug will be excluded. 3. Exclusion criteria also encompass hypersensitivity or a medical history of clinically significant hypersensitivity to probiotics, medications containing probiotic ingredients or lactic acid bacteria, as well as other drugs (e.g., aspirin, antibiotics). 4. Individuals with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption will not be eligible for participation. 5. Participants with positive serologic test results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis will be excluded. 6. Individuals with a history of alcohol and drug abuse or who test positive on a urine drug screening for drug abuse will not be eligible. 7. Participants with following vital signs after at least 3 minutes of rest at screening, will be excluded. ? systolic blood pressure 160 mmHg ? diastolic blood pressure 100 mmHg 8. Individuals with one or more of the following clinical laboratory test results will not be eligible. ? AST (SGOT), ALT (SGPT) > 60 IU/L ? eGFR (CKD-EPI) 10 cigarettes/day) and are unable to quit smoking during hospitalization. 17. persistent alc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment: adverse events, physical examination, vital signs, 12-lead ECG, clinical laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of changes in gut microbiome composition | — |
Countries
Korea, Republic of
Contacts
Public ContactSooYoun Park
Seoul National University Hospital
Outcome results
None listed