RECRUITING

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

Conditions

Healthy Enteric Hyperoxaluria Gastrointestinal disorder Fat malabsorption Urinary oxalate Kidney stones Live Biotherapeutic Product

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-11-16

Study Completion:2024-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05650112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥ 18 to ≤ 50 years. 2. Willing to participate and sign the informed consent form. 3. Available for and agree to comply with all study requirements, including duration of stay at the clinical pharmacology unit, adherence to diet control, study drug administration, follow-up visits, and collection of stool, urine, and blood. 4. Normal clinical laboratory test results which are not considered to be clinically significant by the Investigator at Screening (including an estimated glomerular filtration rate \[eGFR\] \>60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation). 5. Body mass index (BMI) 18 to 35 kg/m2. 6. Volunteers must have 24-hour urinary oxalate \<45 mg.	1. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator. 2. Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. 3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to admission on Day -7 or unwilling to forego other forms of investigational treatment during this study. 4. Major surgery or an inpatient hospital stay within 3 months prior to admission on Day -7. 5. A positive serologic test for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. 6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN). 7. Hemoglobin A1c (HbA1c) ≥6.5 percent. 8. Hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) levels outside the normal reference range. 9. History of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death. 10. Use of prescription drugs (except for hormonal contraceptives) including cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine within 4 weeks prior to Screening and unable or unwilling to refrain from such use through the end of study visit. 11. Use of any herbal or over-the-counter medications, probiotic products, or vitamin supplements, including vitamin C, within 14 days prior to first administration of study drug through the end of the Confinement Period. 12. Planned procedures that may require antibiotics between Screening and the end of study visit. 13. Use of antibiotic treatment up to 4 weeks prior to or during Screening, or between Screening and admission (Day -7), or a history of recurrent infections requiring antibiotics. 14. A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole or other nitroimidazole derivatives. 15. A history of kidney stones. 16. Unwilling to comply with all study procedures and assessments, including the High Oxalate Low Calcium (HOLC) diet and the pretreatment regimen, which includes antibiotics.

Inclusion Criteria

Exclusion Criteria

1. ≥ 18 to ≤ 50 years.
2. Willing to participate and sign the informed consent form.
3. Available for and agree to comply with all study requirements, including duration of stay at the clinical pharmacology unit, adherence to diet control, study drug administration, follow-up visits, and collection of stool, urine, and blood.
4. Normal clinical laboratory test results which are not considered to be clinically significant by the Investigator at Screening (including an estimated glomerular filtration rate \[eGFR\] \>60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation).
5. Body mass index (BMI) 18 to 35 kg/m2.
6. Volunteers must have 24-hour urinary oxalate \<45 mg.

1. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator.
2. Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to admission on Day -7 or unwilling to forego other forms of investigational treatment during this study.
4. Major surgery or an inpatient hospital stay within 3 months prior to admission on Day -7.
5. A positive serologic test for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN).
7. Hemoglobin A1c (HbA1c) ≥6.5 percent.
8. Hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) levels outside the normal reference range.
9. History of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
10. Use of prescription drugs (except for hormonal contraceptives) including cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine within 4 weeks prior to Screening and unable or unwilling to refrain from such use through the end of study visit.
11. Use of any herbal or over-the-counter medications, probiotic products, or vitamin supplements, including vitamin C, within 14 days prior to first administration of study drug through the end of the Confinement Period.
12. Planned procedures that may require antibiotics between Screening and the end of study visit.
13. Use of antibiotic treatment up to 4 weeks prior to or during Screening, or between Screening and admission (Day -7), or a history of recurrent infections requiring antibiotics.
14. A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole or other nitroimidazole derivatives.
15. A history of kidney stones.
16. Unwilling to comply with all study procedures and assessments, including the High Oxalate Low Calcium (HOLC) diet and the pretreatment regimen, which includes antibiotics.

Contacts and Locations

Study Contact

Marguerite Prior, PhD

CONTACT

650-434-8282

mprior@federation.bio

Joumana Zeid

CONTACT

jzeid@federation.bio

Principal Investigator

Andreas Grauer, MD

STUDY_DIRECTOR

Chief Medical Officer

Study Locations (Sites)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227

United States

Collaborators and Investigators

Sponsor: Federation Bio Inc.

Andreas Grauer, MD, STUDY_DIRECTOR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-16

Study Completion Date2024-08-31

Study Record Updates

Study Start Date2022-11-16

Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

Enteric Hyperoxaluria
Gastrointestinal disorder
Fat malabsorption
Urinary oxalate
Kidney stones
Live Biotherapeutic Product

Additional Relevant MeSH Terms

Healthy
Enteric Hyperoxaluria