GEN-001 multiple dose phase 1 study
- Conditions
- Not Applicable
- Registration Number
- KCT0006311
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 12
(1) A healthy adult who is 19 ~50 years old at the screening test
(2) Body mass index (BMI) greater than 18.0 kg / m^2 and less than 28.0 kg / m^2 and body weight greater than 55 kg
? Body Mass Index (BMI) = body weight (kg) / height (m)^2
(3) A person who have no congenital or chronic disease within the last 3 years and have no pathological symptoms or findings as a result of medical examination
(4) A person who has bowel movements of Bristol Stool form scale Type 3-5 more than 3 times a week
(5) A person who has been judged to be suitable for the test subject to be tested at screening such as laboratory tests (hematology test, blood chemistry test, urine test, etc.) and electrocardiogram test conducted according to the characteristics of medicines
(6) A person who signed the written consent to participate in this study with full understanding of the purpose and contents of the examination prior to taking the test
(7) A persion who has the ability and willingness to participate in the study
(1) A person with evidence or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic disease (except for asymptomatic seasonal allergies at the time of administration)
(2) A person with a history of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease) or surgery (except for simple cecal surgery or hernia surgery) that can affect the absorption of drugs
(3) Patients with a history of hypersensitivity to the drug and additives of probiotics or lactic acid bacteria preparetations or other drug(aspirin, antibiotics, etc) and food containing components
(4) Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
(5) Screening If you have a regular alcohol intake history of more than 210 g/week within 6 months (10 g of beer (5%) = 10 g, 1 glass of soju (20%) = 8 g , Wine (12%), 1 cup (125 mL) = 12 g)
(6) Smokers within 3 months of screening
(7) A persion who took other clinical trials or bioequivalence testing drugs within 6 months before the first administration of investigational product
(8) Anyone with a history of major alcohol or drug abuse within a year of screening
(9) A person who is at risk of serious adverse/chronic medical, mental, or laboratory examinations that may increase the risk due to the administration of medicines for clinical trials and participation in testing, or may interfere with the interpretation of test results
(10) A person who is being treated with steroid drugs
(11) A person who took antibiotics within 3 months of the first administration of investigational product
(12) A person who took a proton pump inhibitor (PPI) within 1 month prior to the first administration of investigational product
(13) A person who took prebiotics or probiotics within 1 month prior to the first administration of investigational product (including yogurt products)
(14) A person who took immunosuppressants
(15) A person who have unusual eating habits (e.g. grapefruit juice of 1 L or more per day) or are unable to eat the diet provided in this study
(16) A person who is not willing or able to comply with the guidelines for administering the subjects described in this study protocol
(17) Anyone deemed to be unfit for participation in this examination, as determined by the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative abundance of Lactococcus lactis through 16s rRNA sequencing in feces;Evaluation of safety and tolerability - adverse events, clinical laboratory tests, vital signs, physical examination, and electrocardiogram tests
- Secondary Outcome Measures
Name Time Method Evaluation of intestinal microbial composition through fecal 16s rRNA sequencing;Evaluation of metabolomics in feces;Evaluation of Serum interferon-gamma, TNF-a, IL-1ß, IL-2, IL-7, and IL-15 level ;Evaluation of immune cell fraction by flow cytometry ;Evaluation of bowel activity;Evaluation of vital patch (VP-100)