Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
Public ClinicalTrials.gov record NCT04909723. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04909723
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2, 2021 (Actual)
- Primary completion
- Nov 30, 2022 (Actual)
- Completion
- Apr 6, 2023 (Actual)
- Last update posted
- May 17, 2023
2021 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| Florida Urology Partners | Tampa | Florida | 33615 | — |
| Georgia Clinical Research | Lawrenceville | Georgia | 30044 | — |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | — |
| Indiana University | Carmel | Indiana | 46032 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Chesapeake Urology Associates | Hanover | Maryland | 21076 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University, St. Louis | St Louis | Missouri | 63130 | — |
| Associated Urologists of North Carolina | Raleigh | North Carolina | 27612 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Clinical Research Solutions | Cleveland | Ohio | 44130 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| AMR Knoxville | Knoxville | Tennessee | 37290 | — |
| Knoxville Kidney Center | Knoxville | Tennessee | 37923 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04909723, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04909723 live on ClinicalTrials.gov.