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NCT05657301 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration
A Phase 1 study of Age-related Macular Degeneration, sponsored by Chengdu Origen Biotechnology Co..
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 7
- Study locations
NCT05657301: Active Phase 1 study of Age-related Macular Degeneration, sponsored by Chengdu Origen Biotechnology Co..
NCT05657301 is a Phase 1 study of Age-related Macular Degeneration that is active but no longer recruiting, run by Chengdu Origen Biotechnology Co.. The registered enrollment target is 25 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05657301, a Phase 1 study of Age-related Macular Degeneration, is active but no longer recruiting, sponsored by Chengdu Origen Biotechnology Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 7
- Study locations
Study Summary
VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular intraocular injections.
Primary Outcome
type, severity and incidence of ocular and systemic AEs and SAEs
Conditions Studied
Interventions
- DRUG KH631
Study Locations (7)
Arizona
- Kanghong Investigative Site - Phoenix
Illinois
- Kanghong Investigative Site - Lemont
Massachusetts
- Kanghong Investigative Site - Boston
Nevada
- Kanghong Investigative Site - Reno
New Jersey
- Kanghong Investigative Site - Cherry Hill
Tennessee
- Kanghong Investigative Site - Germantown
Texas
- Kanghong Investigative Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What the registry record for NCT05657301 still lists
NCT05657301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which KH631 is the first listed.
NCT05657301 lists 7 locations in 7 states (Arizona, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05657301 about?
NCT05657301 is a clinical study titled "Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration". VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-...
What is the current status of trial NCT05657301?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-10-16. Estimated completion is 2027-09.
What conditions does trial NCT05657301 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT05657301?
The interventions under investigation include: KH631 (DRUG).
Who is sponsoring clinical trial NCT05657301?
This trial is sponsored by Chengdu Origen Biotechnology Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05657301 being conducted?
This trial has 7 study locations across Arizona, Illinois, Massachusetts, Nevada, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Age-related Macular Degeneration
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Where NCT05657301's enrollment target sits among peer trials
25 62nd of 74 higher than 12 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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