Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyp… (NCT05650112) | Clinical Trial Compass
UnknownPhase 1
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
United States48 participantsStarted 2022-11-16
Plain-language 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.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. ≥ 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Subjects With Treatment-Emergent Adverse Events