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FB-001 for Enteric Hyperoxaluria

Phase 1
Recruiting
Research Sponsored by Federation Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 196 days
Awards & highlights

Study Summary

This trial is evaluating a drug's safety and effectiveness in healthy volunteers & people with enteric hyperoxaluria. Participants receive the drug & are monitored for safety.

Who is the study for?
This trial is for healthy adults and those with enteric hyperoxaluria, a condition causing high urinary oxalate due to gastrointestinal disorders. Participants must be 18-74 years old with normal lab results, BMI of 18-40 kg/m2, and stable on any kidney stone risk management meds. Exclusions include genetic causes of kidney stones, recent other trials or surgeries, certain infections or diseases, abnormal blood tests, unstable thyroid levels, and use of specific medications.Check my eligibility
What is being tested?
The study is testing FB-001's safety in two parts: first in healthy volunteers and then in subjects with enteric hyperoxaluria. It's randomized (participants are put into groups by chance), double-blinded (neither participants nor researchers know who gets the real treatment), placebo-controlled (some get a fake treatment for comparison). Safety monitoring follows administration.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and tolerability, exact side effects aren't listed but may include typical drug-related reactions such as digestive issues, allergic responses or skin irritations. Monitoring will identify potential side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~196 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 196 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects With Treatment-Emergent Adverse Events

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: FB-001 Healthy VolunteerExperimental Treatment1 Intervention
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.
Group II: FB-001 Enteric HyperoxaluriaExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
Healthy volunteer participants receive placebo once a day, orally, for 10 days in Part 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Federation Bio Inc.Lead Sponsor
Andreas Grauer, MDStudy DirectorChief Medical Officer
2 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

FB-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05650112 — Phase 1
Enteric Hyperoxaluria Research Study Groups: FB-001 Enteric Hyperoxaluria, FB-001 Healthy Volunteer, Placebo
Enteric Hyperoxaluria Clinical Trial 2023: FB-001 Highlights & Side Effects. Trial Name: NCT05650112 — Phase 1
FB-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650112 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for new participants in this clinical experiment?

"At present, this trial is in the process of recruiting participants. According to clinicaltrials.gov, it was initially posted on December 8th 2022 and updated most recently on December 6th 2022."

Answered by AI

How many participants are being enlisted in this experiment?

"That is correct. As per the information on clinicaltrials.gov, this medical trial has been open for enrollment since December 8th 2022 and was most recently modified on December 6th 2022. The team are recruiting 48 individuals from a single site."

Answered by AI

What risks could arise from the use of FB-001 Healthy Volunteer on individuals?

"As this is a Phase 1 trial, with only limited data present to support the safety and efficacy of FB-001 Healthy Volunteer, we have assigned it a score of 1."

Answered by AI

Could I potentially qualify to join this clinical experiment?

"This clinical trial seeks 48 participants with enteric hyperoxaluria between the ages of 18 and 74. Notably, applicants must meet certain criteria including: having 24-hour urinary oxalate levels less than 45 mg., being aged between 18 to 50 years old., consenting to participate in the study by signing an informed consent form, agreeing to comply with all requirements of the study such as duration at a clinical pharmacology unit and dietary restrictions, passing normal laboratory test results which are not clinically significant according to investigators (including estimated glomerular filtration rate [eGFR] >60 mL/min/1.73 m2"

Answered by AI

Does the research protocol for this trial include participants that are at least 20 years in age?

"Patients that meet the age qualification of 18 years or older and younger than 74 years old may be considered for recruitment in this trial."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Medpace Clinical Pharmacology Unit
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I like volunteering for clinical trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
2022. "Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650112.
~9 spots leftby Aug 2024
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