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NCT05835895 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis
A Phase 1 study of Knee Osteoarthritis and Osteoarthritis, Knee, sponsored by Genascence Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 9
- Study locations
NCT05835895 is a Phase 1 study of Knee Osteoarthritis and Osteoarthritis, Knee that is active but no longer recruiting, run by Genascence Corporation. The registered enrollment target is 67 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (78% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT05835895, a Phase 1 study of Knee Osteoarthritis and Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Genascence Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 9
- Study locations
Study Summary
The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.
Conditions Studied
Interventions
- DRUG Placebo
- GENETIC GNSC-001
- DRUG transient immune-modulation
Study Locations (9)
Florida
- Well Pharma Medical Research - Miami
- South Florida Research - Miami Springs
- Premier Medical Associates - The Villages
California
- Biosolutions Clinical Research Center - La Mesa
- UC San Diego - San Diego
Alabama
- Alliance for Medical Research Mobile - Mobile
Missouri
- Alliance for Multispecialty Research Kansas City - Kansas City
North Carolina
- West Clinical Research - Morehead City
Pennsylvania
- Altoona Center for Clinical Research - Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835895
The ClinicalTrials.gov registry entry for NCT05835895 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (78% lower). The listed sponsor is Genascence Corporation, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05835895 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05835895 about?
NCT05835895 is a clinical study titled "Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis". The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.
What is the current status of trial NCT05835895?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2023-06-12. Estimated completion is 2029-05.
What conditions does trial NCT05835895 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Osteoarthritis, Knee, Osteo Arthritis Knee.
What interventions are being tested in trial NCT05835895?
The interventions under investigation include: Placebo (DRUG), GNSC-001 (GENETIC), transient immune-modulation (DRUG).
Who is sponsoring clinical trial NCT05835895?
This trial is sponsored by Genascence Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835895 being conducted?
This trial has 9 study locations across Alabama, California, Florida, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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