Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Study ID
NCT06458595
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • KH658 — DRUG
    KH658 Ophthalmic Injection

Study Details

KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

Key Dates

First listed
Jun 13, 2024
Start date
Jun 28, 2024
Status verified
Jun 2024
Primary completion
Mar 31, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: KH658

Primary Outcome Measure

Tolerability and safety of KH658 in different dose levels [ Time Frame: Week 4， Week 26 ]

Central Contacts

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Age-related macular degeneration trialsOphthalmology trialsRetina trials

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