A phase 1 clinical trial to evaluate the safety, tolerability, and composition of intestinal microbiome after oral administration of IMB002 in healthy male subjects

Not Applicable

• Conditions: Not Applicable

• Registration Number: KCT0009482
• Lead Sponsor: ImmunoBiome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 18

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

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 < 80 mmHg or > 160 mmHg
? diastolic blood pressure < 50 mmHg or > 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) < 60 mL/min/1.73m²
9. Participants who have taken any ETC(Ethical drug) or herbal medication within 14 days prior to the scheduled first dose of the investigational drug, or any OTC (over-the-counter) medication or dietary supplement (including liver function supplements or vitamins) within 7 days prior to the scheduled first dose, will be excluded, unless otherwise deemed reasonable by the investigator.
10. Individuals who have taken a proton pump inhibitor (PPI) within 14 days prior to the scheduled first dose of the investigational drug will not be eligible for participation.
11. Individuals who have taken probiotics, prebiotics, or other lactic acid bacteria-containing products (including yogurt products) within 1 month prior to the scheduled first dose of the investigational product.
12. Individuals who have taken antibiotics within 1 month prior to the scheduled first dose of the investigational product.
13. Individuals who have taken steroidal medications or immunosuppressants within 2 months prior to the scheduled first dose of the investigational product.
14. Participation in another clinical trial (including bioequivalence studies) in which other investigational drug was administered within 6 months prior to the scheduled first dose of the investigational drug.
15. Individuals who have donated whole blood within 2 months or donated component blood or received a blood transfusion within 1 month prior to the first scheduled dose of the investigational drug.
16. Individuals who are heavy smokers (>10 cigarettes/day) and are unable to quit smoking during hospitalization.
17. persistent alc

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified