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Trial record 1 of 1 for:    novome | Hyperoxaluria
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Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

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ClinicalTrials.gov Identifier: NCT04909723
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Novome Biotechnologies Inc

Study Description
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Brief Summary:

The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Enteric Hyperoxaluria Combination Product: NOV-001 Biological: NB1000S Drug: NB2000P Drug: Placebo Phase 1 Phase 2

Detailed Description:
This study is evaluating the safety, tolerability, pharmacodynamics, and early efficacy of NOV-001. NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide. In Stage 1, NB1000S (or placebo) is administered on the first day of treatment and NB2000P is administered once daily, or as indicated in the adaptive study design. In Stage 2, NB1000S (or placebo) is administered two times per day on the first day of the treatment and NB2000P (or placebo) is administered once daily for 28 days, at doses determined in Stage 1.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Stage 1 placebo arm Drug: Placebo
Placebo
Experimental: Stage 1 NB1000S 10^9 CFU one time on Day 1 Biological: NB1000S
A recombinant live biotherapeutic product.
Experimental: Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/day Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Experimental: Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/day Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Experimental: (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.
 Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Experimental: Stage 1 NB2000P at a dose to be determined Drug: NB2000P
A botanically derived polysaccharide.
Experimental: 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.
 Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.
Placebo Comparator: Stage 2 placebo arm
In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive placebo for 28 days.
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: Up to 182 days ]

Other Outcome Measures:
  1. NB1000S engraftment as measured by quantitative Polymerase Chain Reaction (qPCR) determination of concentration of NB1000S strain genomic copies (cells/mL) in stool, change from baseline. [ Time Frame: Up to 182 days ]
  2. The proportion of subjects with NB100S strain abundance in stool, as measured by qPCR determination of concentration of strain genomic copies (cells/mL). [ Time Frame: Up to 182 days ]
  3. Time to strain engraftment, based on the time to reach NB1000S strain abundance by qPCR determination of concentration of NB1000S strain genomic copies (cells/mL). [ Time Frame: Up to 182 days ]
  4. Fecal shedding of NB1000S strain as measured by qPCR determination of concentration of NB1000S strain genomic copies (cells/mL), during treatment and follow-up periods. [ Time Frame: Up to 182 days ]
  5. Absolute change from baseline in 24-hour urinary oxalate (UOx) excretion (mg/mL), NOV-001 compared to placebo. [ Time Frame: Stage 2; 28 days ]
  6. Percent change from baseline in 24-hour UOx excretion (mg/mL), NOV-001 compared to placebo. [ Time Frame: Stage 2; 28 days ]
  7. Proportion of patients achieving ≥ 20% reduction in 24-hour UOx excretion from baseline to end of treatment, NOV-001 compared to placebo. [ Time Frame: Stage 2; 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Stage 1 Key Inclusion Criteria:

  • Ages 18 to 55
  • 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.

Stage 1 Key Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening.
  • 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.

Stage 2 Key Inclusion Criteria:

  • 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.

Stage 2 Key Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909723


Contacts
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Contact: Lachy McLean, MB ChB, PhD 415-894-0999 lmclean@novomebio.com
Contact: Polina Bukshpun pbukshpun@novomebio.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Annalia Mefford    205-500-1358    amefford@uabmc.edu   
Principal Investigator: Kyle Wood         
United States, California
National Institute of Clinical Research Active, not recruiting
Garden Grove, California, United States, 92844
United States, Florida
Advanced Urology Institute Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Jonelle Horsley    386-239-8535    jonelle.horsley@auihealth.com   
Principal Investigator: Samuel Lawindy         
Prohealth Research Center Recruiting
Doral, Florida, United States, 33166
Contact: Johanna Garcia    305-960-7934    jgarcia@prohealthresearchcenter.com   
Principal Investigator: Ronald Lubetsky         
Florida Urology Partners Recruiting
Tampa, Florida, United States, 33615
Contact: Linda Sibert    813-875-8567    linda@gulfcoastcta.com   
Principal Investigator: Osvaldo Padron         
United States, Georgia
Georgia Clinical Research Recruiting
Lawrenceville, Georgia, United States, 30044
Contact: Janet Williams    678-822-5581    Georgiaclinicalresearch@comcast.net   
Principal Investigator: John Lentz         
United States, Indiana
Indiana University Recruiting
Carmel, Indiana, United States, 46032
Contact: Kimberly Smoot       ksmoot@iuhealth.org   
Principal Investigator: James Lingeman         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carly Banks    507-255-4347    Banks.Carly@mayo.edu   
Principal Investigator: John Lieske         
United States, Missouri
Washington University, St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Teresa Arb    314-747-1217    arbt@wustl.edu   
Principal Investigator: Seth Goldberg         
United States, North Carolina
Associated Urologists of North Carolina Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Kip Moffett    919-390-7368    kmoffett@AUNCUrology.com   
Principal Investigator: Mark Jalkut         
United States, Ohio
Clinical Research Solutions Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Jenny G Simpkins    440-340-9010    JSimpkins@crssites.com   
Principal Investigator: Lawrence Gervasi         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: David Sobel         
United States, Tennessee
AMR Knoxville Active, not recruiting
Knoxville, Tennessee, United States, 37920
Knoxville Kidney Center Recruiting
Knoxville, Tennessee, United States, 37923
Contact: Salina Hamby    865-692-3462    shambykkcnurse@gmail.com   
Principal Investigator: George Newman         
United States, Texas
Houston Metro Urology Recruiting
Houston, Texas, United States, 77027
Contact: Carolyn Molina    713-351-5000    carolyn.molina@hmutx.com   
Principal Investigator: Zvi Schiffman         
Sponsors and Collaborators
Novome Biotechnologies Inc
Investigators
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Study Director: Lachy McLean, MB ChB, PhD Novome Biotechnologies Inc
More Information
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Responsible Party: Novome Biotechnologies Inc
ClinicalTrials.gov Identifier: NCT04909723    
Other Study ID Numbers: NOV-001-CL01
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novome Biotechnologies Inc:
Enteric hyperoxaluria
Hyperoxaluria
Secondary hyperoxaluria
Healthy volunteers
Safety
Tolerability
Kidney stone
 Roux-en-Y gastric bypass
Oxalate
Kidney calcification
Gastric bypass
Biliopancreatic diversion with duodenal switch
Duodenal switch