None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : This clinical trial was conducted using a randomized, single-blind, placebo-controlled design with different dose groups. The investigational product, GEN-001 (La
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for participation in the study: Healthy adults aged between 19 and 55 years at the time of screening. Body weight = 55 kg for males and = 50 kg for females. Body mass index (BMI) between 18.5 and 27.0 kg/m² (BMI = weight (kg) / [height (m)]²). Male participants who are sexually active with women of childbearing potential must agree to use effective contraception (e.g., condom in combination with a diaphragm or cervical cap) and refrain from donating sperm during the study period and for at least 6 months after the last dose of the investigational product. (This requirement does not apply if the male participant or his female partner is confirmed to be infertile.) Have a bowel movement at least three times per week, with Bristol Stool Form Scale type 3 to 5. Female participants must meet at least one of the following criteria: Postmenopausal, defined as no natural menstrual bleeding for at least 2 consecutive years. Surgically sterile, including hysterectomy, bilateral oophorectomy, tubal ligation, or other confirmed methods of sterilization. Have voluntarily signed the informed consent form (ICF) after being fully informed of the study’s nature, procedures, and potential risks, and agree to comply with the study requirements.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following conditions: History or presence of clinically significant diseases in the hepatobiliary system (e.g., severe liver dysfunction), renal system (e.g., severe renal impairment), nervous system, immune system, respiratory system, endocrine system, hematologic/oncologic system, cardiovascular system (e.g., heart failure), or allergic conditions (e.g., allergic rhinitis, atopic dermatitis, asthma), or any psychiatric disorders. History of gastrointestinal diseases or surgeries (e.g., Crohn’s disease, ulcerative colitis) that could affect the absorption of the investigational product (excluding simple appendectomy or hernia repair). History of clinically significant hypersensitivity to probiotics, lactic acid bacteria preparations, or any of their excipients. Individuals with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Determined to be ineligible based on screening assessments (e.g., medical history, blood pressure, 12-lead ECG, physical examination, clinical laboratory tests) conducted within 28 days prior to the first dose of the investigational product, including: AST or ALT > 1.5 times the upper limit of normal (ULN) Total bilirubin > 1.5 times ULN eGFR 150 mmHg or 100 mmHg or 10 cigarettes/day), caffeine (>5 cups/day), or alcohol (>210 g/week). Participation in another clinical trial (including bioequivalence studies) and administration of an investigational product within 180 days before the first dose (longer washout may be applied depending on the half-life of biologics). Donation of whole blood within 60 days, or donation of blood components within 30 days before the first dose. Received a blood transfusion within 30 days prior to the first dose. Deemed unsuitable for participation by the investigator for any other reason, including abnormal clinical laboratory results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolite Profile in Blood Before and After GEN-001 Administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolite Profile in Feces Before and After GEN-001 Administration;Metabolite Profile in urine Before and After GEN-001 Administration;Safety assessment after administration of GEN-001 or placebo | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Kyu Choi
Yonsei University Health System, Severance Hospital
Outcome results
None listed