[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nterica Bio inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100573769","phase-1-safety-and-tolerability-of-ntr-101-in-patients-with-acute-alcohol-associated-hepatitis-100573769",false,"NCT06750588","Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis","Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis","PhoenixAH","Key Inclusion Criteria:\n\n* Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers\n* Able to provide written informed consent (either from patient or patient's legally authorized representative)\n* Male and female patients aged ≥18 years and ≤ 70 years of age\n* BMI ≥ 20 to ≤ 40 kg\u002Fm2\n* Enterococcus faecalis testing\n* Susceptibility to NTR-101\n* Women of child-bearing potential and male patients must agree to use a medically acceptable method of contraception\u002F birth control throughout the study duration.\n\nKey Exclusion Criteria:\n\n* Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol\n* Participants taking systemic corticosteroids for a specified duration\n* Platelet count below specified ranges\n* INR and Serum creatinine levels above specified ranges\n* Active bacterial or viral infections\n* Other or concomitant cause(s) of liver disease as a result of other conditions\n* Co-infection with HIV\n* Positive urine drug screen\n* Any significant systemic or major illness other than liver disease that, in the opinion of the investigator, would preclude the patient from participating in and completing the study or might complicated or exacerbated by the proposed treatments or might confound assessment of investigational product\n* If female, known pregnancy, or has a positive serum pregnancy test, or lactating\u002F breastfeeding","ALL","18 Years","70 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH).\n\nThe drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role.\n\nThe main questions it aims to answer are:\n\nAre multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center.\n\nParticipants will:\n\nBe administered multiple ascending dose frequencies of NTR-101 every day for 7 days.\n\nStay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days.\n\nKeep a diary of their symptoms until the checkups and tests are completed.",[28],"Alcohol-Associated Hepatitis",[30,31,32,33],"bacteriophages","alcohol-associated hepatitis","NTR-101","bacteriophage therapy","NOT_YET_RECRUITING","2025-08-13",{"date":37,"type":38},"2025-08-17","ACTUAL",{"date":40,"type":22},"2025-11-05",{"date":42,"type":22},"2026-06",{"name":44,"class":45},"Nterica Bio inc","INDUSTRY",""]