Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 2, 2021

Primary Completion Date

November 30, 2022

Study Completion Date

April 6, 2023

Conditions
Healthy VolunteersEnteric Hyperoxaluria
Interventions
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.

BIOLOGICAL

NB1000S

A recombinant live biotherapeutic product.

DRUG

NB2000P

A botanically derived polysaccharide.

DRUG

Placebo

Placebo

Trial Locations (20)

21076

Chesapeake Urology Associates, Hanover

27612

Associated Urologists of North Carolina, Raleigh

30044

Georgia Clinical Research, Lawrenceville

32114

Advanced Urology Institute, Daytona Beach

33166

Prohealth Research Center, Doral

33615

Florida Urology Partners, Tampa

35205

University of Alabama at Birmingham, Birmingham

37290

AMR Knoxville, Knoxville

37923

Knoxville Kidney Center, Knoxville

44130

Clinical Research Solutions, Cleveland

45267

University of Cincinnati, Cincinnati

46032

Indiana University, Carmel

52242

University of Iowa Hospitals and Clinics, Iowa City

55905

Mayo Clinic, Rochester

63130

Washington University, St. Louis, St Louis

77027

Houston Metro Urology, Houston

83642

Idaho Urologic Institute, Meridian

85259

Mayo Clinic, Scottsdale

02906

The Miriam Hospital, Providence

QC G2J 0C4

Alpha Recherche Clinique, Québec

Sponsors
All Listed Sponsors
lead

Novome Biotechnologies Inc

INDUSTRY