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

NCT05650112 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

  • Healthy
  • Enteric Hyperoxaluria

Interventions

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

Sponsors & Collaborators

  • Federation Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Andreas Grauer, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650112 on ClinicalTrials.gov