Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Healthy Volunteers, Enteric Hyperoxaluria
In brief
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.
Key facts
- Study ID
- NCT04909723
- Run by
- Novome Biotechnologies Inc
- People needed
- 153
- Starts
- 2021-06-02
- Expected to finish
- 2023-04-06
- Last updated by the study team
- 2023-05-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.