A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)

Exclusion Criteria

• •Body mass index ≥40.0 kg/m2
• •Life expectancy of ≤12 months
• •Inpatient (in hospital or skilled nursing facility) at the time of randomization
• •Current (i.e., qualifying) CDI episode required admission to an Intensive Care Unit
• •Pregnant, breastfeeding, or seeking pregnancy while on study
• •Have, as determined by the Investigator, a history or clinical/laboratory manifestations of significant neurological, renal, hepatic, hematologic, cardiac, pulmonary, metabolic, endocrine, psychiatric, GI disorders other than CDI (including infectious, ischemic, or immunological diseases), human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection, or other condition that could interfere with the evaluation of safety or efficacy, or put the subject at risk of harm from study participation
• •Have an active malignancy of any type or history of a malignancy within past 5 years, except for treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• •Have an acute febrile illness (fever \>38°C \[100.4°F\]) at Day 1
• •Drug, alcohol, or substance dependence within the last 2 years
• •Any of the following laboratory results at Screening:
• •* White blood cell count ≥15,000 cells/mm3
• •* Absolute neutrophil count \<1000/mm3
• •* Liver function test result (e.g., aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), or total bilirubin) of ≥3 times the upper limit of normal
• •* Serum albumin \<3 g/dL
• •* Serum creatinine \>1.8 mg/dL and oliguric
• •Use of systemic antibiotic therapy for conditions other than CDI within 7 days of randomization or expectation to require antibiotic therapy for conditions other than CDI for 12 weeks following the first dose of study drug for Cohort A or 16 weeks following the first dose of study drug for Cohort B, including subtherapeutic doses of oral antibiotics (e.g., for rosacea)
• •Have a known immunodeficiency disorder, including but not limited to:
• •* An immunodeficiency disease
• •* Receiving, or plans to receive, treatment with systemic corticosteroids equivalent to \>10 mg prednisone per day
• •* Receiving, or plans to receive, myelosuppressive chemotherapy
• •Previous fecal transplant or live biotherapeutic product within 1 year of randomization
• •Treatment with bezlotoxumab (Zinplava™) for the qualifying CDI episode
• •Diagnosis of inflammatory bowel disease (including but not limited to: Crohn's disease, ulcerative colitis, microscopic colitis)
• •Active irritable bowel syndrome \[those with diarrhea predominant or alternating constipation and diarrhea\] (in past 6 months based on Rome IV criteria and subject deemed not suitable for study by Investigator's judgment)
• •Celiac disease not well controlled on gluten-free diet
• •Active gastroparesis, toxic megacolon, pseudomembranous colitis, colostomy, intestinal resection (except appendectomy), ileus or short gut syndrome
• •History of chronic diarrhea apart from prior CDI
• •Intra-abdominal surgery, including laparoscopic procedures, within 8 weeks of Screening (appendectomy and cholecystectomy excluded)
• •History of difficulty swallowing food or liquids
• •Taking antidiarrheal agents (e.g., loperamide) or laxatives (e.g., senna) on a regular basis
• •Use of non-dietary probiotic supplements within 7 days of Day 1 or plan to use non-dietary probiotic supplements while on study through Week 12 in Cohort A and Week 16 in Cohort B
• •Known to have consumed fermented or other foods that may contain B. amyloliquefaciens (such as miso, soybean paste, or fermented rice- or locust bean-derived products) within 7 days prior to Day 1, or plan to consume them prior to Week 12 for Cohort A and prior to Week 16 for Cohort B
• •Participation in a clinical trial of an investigational drug or medical device within 30 days or 5 half-lives, whichever is longer, prior to the Screening visit