SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.

Inclusion criteria

• Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
• Male or female subjects ≥ 18 years.
• A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

Exclusion criteria

• Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Active irritable bowel syndrome with diarrhea within the previous 12 months.
• Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
• History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
• Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
• Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
• Absolute neutrophil count < 500 cells/mm3