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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 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.

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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.

Conditions Studied

Age-related Macular Degeneration

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

FieldValue
Enrollment Target 25 participants
Start Date 2023-10-16
Est. Completion 2027-09
Phase Phase 1

Sponsor

Chengdu Origen Biotechnology Co.

2 total trials

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What the Registry Record Tells You About NCT05657301

The ClinicalTrials.gov registry entry for NCT05657301 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (98% lower). The listed sponsor is Chengdu Origen Biotechnology Co., which has 2 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.