Healthy Clinical Trial
Official title:
A Study of the Safety, Tolerability, Microbial Kinetics and Effect on Urinary Oxalate Excretion of FB-001 in Healthy Volunteers Fed a High Oxalate/Low Calcium Diet and in Patients With Enteric Hyperoxaluria
This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2). Eligible participants receive investigational product and undergo safety monitoring, evaluations and subsequent follow-up after investigational product administration.
This study is evaluating the safety, tolerability and microbial kinetics of FB-001 within the following 2 study parts: Part 1 is an inpatient, placebo-controlled, study in 32 healthy volunteer male and female participants (16 treated: 16 placebo) for 10 days of dosing consisting of a loading dose of 1 × 10^12 viable cells administered orally on Day 1 and Day 2 and a dose of 1 × 10^11 viable cells administered orally on Day 3 to Day 10. Part 2 is an outpatient open label study in up to 16 adult male and female participants with enteric hyperoxaluria, defined as increased gastrointestinal oxalate absorption in the context of fat malabsorption and/or increased intestinal permeability to oxalate caused by gastrointestinal disorders. Participants will receive FB-001 for 10 days consisting of a loading dose of 1 × 10^12 viable cells administered orally on Day 1 and Day 2 and a dose of 1 × 10^11 viable cells administered orally on Day 3 to Day 10. ;
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