NCT05650112

Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Federation Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy
• Enteric Hyperoxaluria

Interventions

Type	Name	Description
BIOLOGICAL	FB-001	FB-001 is formulated as a powder in capsule intended for oral administration
BIOLOGICAL	Placebo	In order to maintain study blinding, matching placebo in identical packaging is manufactured using an inactive powder in capsule

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-12-14
• Last updated: 2023-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study