NCT04909723

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
2 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

May 7, 2021

Last Update Submit

May 16, 2023

Conditions

Healthy VolunteersEnteric Hyperoxaluria

Keywords

Healthy volunteersSafetyTolerabilityEnteric hyperoxaluriaKidney stoneRoux-en-Y gastric bypassHyperoxaluriaSecondary hyperoxaluriaOxalateKidney calcificationGastric bypassBiliopancreatic diversion with duodenal switchDuodenal switch

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Up to 182 days

Other Outcomes (7)

  • 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.

    Up to 182 days

  • The proportion of subjects with NB100S strain abundance in stool, as measured by qPCR determination of concentration of strain genomic copies (cells/mL).

    Up to 182 days

  • 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).

    Up to 182 days

  • +4 more other outcomes

Study Arms (8)

Stage 1 placebo arm

PLACEBO COMPARATOR
Drug: Placebo

Stage 1 NB1000S 10^9 CFU one time on Day 1

EXPERIMENTAL
Biological: NB1000S

Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/day

EXPERIMENTAL
Combination Product: NOV-001

Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/day

EXPERIMENTAL
Combination Product: NOV-001

(Optional) Stage 1 variable doses of NB1000S and NB2000P at varying dosing regimens.

EXPERIMENTAL

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

Stage 1 NB2000P at a dose to be determined

EXPERIMENTAL
Drug: NB2000P

Stage 2 NOV-001 at dose determined in Stage 1

EXPERIMENTAL

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

Stage 2 placebo arm

PLACEBO COMPARATOR

In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive placebo for 28 days.

Drug: Placebo

Interventions

NOV-001COMBINATION_PRODUCT

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.Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/dayStage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/dayStage 2 NOV-001 at dose determined in Stage 1
NB1000SBIOLOGICAL

A recombinant live biotherapeutic product.

Stage 1 NB1000S 10^9 CFU one time on Day 1
NB2000PDRUG

A botanically derived polysaccharide.

Stage 1 NB2000P at a dose to be determined
PlaceboDRUG

Placebo

Stage 1 placebo armStage 2 placebo arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Ages 18 to 65.
  • Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic diversion with duodenal switch (BPD-DS) surgery.
  • 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.
  • 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.)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

Location

Prohealth Research Center

Doral, Florida, 33166, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Georgia Clinical Research

Lawrenceville, Georgia, 30044, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

Indiana University

Carmel, Indiana, 46032, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Chesapeake Urology Associates

Hanover, Maryland, 21076, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63130, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Clinical Research Solutions

Cleveland, Ohio, 44130, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37290, United States

Location

Knoxville Kidney Center

Knoxville, Tennessee, 37923, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Alpha Recherche Clinique

Québec, Quebec, QC G2J 0C4, Canada

Location

MeSH Terms

Conditions

Kidney CalculiHyperoxaluria

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lachy McLean, MB ChB, PhD

    Novome Biotechnologies Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

June 2, 2021

Study Start

June 2, 2021

Primary Completion

November 30, 2022

Study Completion

April 6, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(19)CA(1)