Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
NCT ID: NCT04909723
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2021-06-02
2023-04-06
Brief Summary
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The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stage 1 placebo arm
Placebo
Placebo
Stage 1 NB1000S 10^9 CFU one time on Day 1
NB1000S
A recombinant live biotherapeutic product.
Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/day
NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/day
NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
(Optional) Stage 1 variable doses of NB1000S and NB2000P at varying dosing regimens.
Adaptive trial design supports the enrollment of additional arms with variable doses of NB1000S, NB2000P, at varying frequencies of NB1000S and NB2000P administrations.
NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Stage 1 NB2000P at a dose to be determined
NB2000P
A botanically derived polysaccharide.
Stage 2 NOV-001 at dose determined in Stage 1
In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive NOV-001 (consisting of NB1000S and NB2000P at a dose and regimen determined in Stage 1) for 28 days.
NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Stage 2 placebo arm
In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive placebo for 28 days.
Placebo
Placebo
Interventions
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NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
NB1000S
A recombinant live biotherapeutic product.
NB2000P
A botanically derived polysaccharide.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \< 38 kg/m2.
* Healthy as defined by no clinically relevant abnormalities being identified by a detailed medical history, physical examination, and clinical laboratory tests.
* If woman of child-bearing potential, must not be pregnant, and must also agree to use an appropriate highly-effective contraceptive.
* Willing and able to comply with all study requirements, including duration of stay at inpatient unit, dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and urine collections.
* Ages 18 to 65.
* Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic diversion with duodenal switch (BPD-DS) surgery.
* 24-Hour urinary oxalate (UOx) ≥ 60 mg.
* If woman of child-bearing potential, must not be pregnant and must also agree to use an appropriate highly effective contraceptive method.
* Must, in the opinion of the Investigator, be in otherwise good health.
* Willing and able to comply with all study requirements, including dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and 24-hour urine collections.
Exclusion Criteria
* Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study.
* Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study.
* Participation in any investigational intervention study within 30 days prior to study product administration in this study.
* Known hypersensitivity to omeprazole.
* Applicable only to certain study groups depending on emerging Stage 1 data: no current or anticipated use during the screening or treatment periods of the study of medications that have the potential for drug-drug interactions (DDI) with omeprazole.
* Chronic kidney disease with eGFR \< 30 mL/min/1.73 m2 at Screening.
* Evidence of current acute renal injury or ongoing clinically significant renal disease.
* Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study (topical antibiotics are permissible.)
* Taking during the study any treatment for hyperoxaluria except for NOV-001, other than stable treatments for the management of kidney stones.
* Taking Vitamin C ≥ 300 mg/day for \> 10 days within 7 days prior to Screening; unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the duration of study product treatment.
* Known active autoimmune disorder or other condition requiring high dose of systemic corticosteroids (i.e., \> 10 mg/day prednisone or equivalent) or other immunosuppressant therapy.
* Current or history of any clinically significant medical illness or disorder other than enteric hyperoxaluria that the Investigator considers should exclude the patient from the study.
* Participation in any investigational intervention study within 30 days prior to study product administration in this study.
* Known hypersensitivity to omeprazole.
18 Years
65 Years
ALL
Yes
Sponsors
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Novome Biotechnologies Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Lachy McLean, MB ChB, PhD
Role: STUDY_DIRECTOR
Novome Biotechnologies Inc
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Prohealth Research Center
Doral, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Georgia Clinical Research
Lawrenceville, Georgia, United States
Idaho Urologic Institute
Meridian, Idaho, United States
Indiana University
Carmel, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Chesapeake Urology Associates
Hanover, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University, St. Louis
St Louis, Missouri, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Clinical Research Solutions
Cleveland, Ohio, United States
The Miriam Hospital
Providence, Rhode Island, United States
AMR Knoxville
Knoxville, Tennessee, United States
Knoxville Kidney Center
Knoxville, Tennessee, United States
Houston Metro Urology
Houston, Texas, United States
Alpha Recherche Clinique
Québec, Quebec, Canada
Countries
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Other Identifiers
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NOV-001-CL01
Identifier Type: -
Identifier Source: org_study_id
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