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

NCT05650112 | Unknown Phase 1 FDA Drug

• 1 other identifier: FB-001-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-Emergent Adverse Events

  Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after the first dose of study treatment. TEAEs are considered treatment-related if relationship to study drug is possibly related, probably related, or definitely related.

  196 days

Study Arms (3)

FB-001 Healthy Volunteer

EXPERIMENTAL

Healthy volunteer participants in Part 1 receive FB-001 (1 x 10\^12 viable cells) orally on Day 1 and Day 2 and FB-001 (1 x 10\^11 viable cells) orally on Days 3 to 10.

Biological: FB-001

Placebo

PLACEBO COMPARATOR

Healthy volunteer participants receive placebo once a day, orally, for 10 days in Part 1.

Biological: Placebo

FB-001 Enteric Hyperoxaluria

EXPERIMENTAL

Enteric hyperoxaluria participants in Part 2 receive FB-001 (1 x 10\^12 viable cells) orally on Day 1 and Day 2 and FB-001 (1 x 10\^11 viable cells) orally on Days 3 to 10.

Biological: FB-001

Interventions

FB-001 BIOLOGICAL

FB-001 is formulated as a powder in capsule intended for oral administration

FB-001 Enteric Hyperoxaluria; FB-001 Healthy Volunteer

Placebo BIOLOGICAL

In order to maintain study blinding, matching placebo in identical packaging is manufactured using an inactive powder in capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 to ≤ 50 years.
• Willing to participate and sign the informed consent form.
• 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.
• 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).
• Body mass index (BMI) 18 to 35 kg/m2.
• Volunteers must have 24-hour urinary oxalate \<45 mg.

You may not qualify if:

• Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator.
• Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• 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.
• Major surgery or an inpatient hospital stay within 3 months prior to admission on Day -7.
• A positive serologic test for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN).
• Hemoglobin A1c (HbA1c) ≥6.5 percent.
• Hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) levels outside the normal reference range.
• History of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
• 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.
• 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.
• Planned procedures that may require antibiotics between Screening and the end of study visit.
• 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.
• A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole or other nitroimidazole derivatives.
• A history of kidney stones.

Sponsors & Collaborators

• Federation Bio Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases; Kidney Calculi

Condition Hierarchy (Ancestors)

Digestive System Diseases; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Grauer, MD

  Chief Medical Officer

  STUDY DIRECTOR

Central Study Contacts

Marguerite Prior, PhD

CONTACT

650-434-8282; mprior@federation.bio

Joumana Zeid

CONTACT

jzeid@federation.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Part 1 is double blind. Part 2 is open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 - randomized, placebo-controlled. Part 2 - open label.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: November 16, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)