Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Study ID
NCT05672121
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • KH631 — DRUG
    KH631: AAV vector containing a coding sequence for an anti-VEGF protein

Study Details

KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal 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
Jan 5, 2023
Start date
Feb 6, 2023
Status verified
Nov 2024
Primary completion
Dec 28, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KH631 Dose 1
    dose1:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.
  • Experimental: KH631 Dose 2
    dose2:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.
  • Experimental: KH631 Dose 3
    dose3:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.
  • Experimental: KH631 Dose 4
    dose4:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.
  • Experimental: KH631 Dose 5
    dose5:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection.

Primary Outcome Measure

Safety [ Time Frame: 24 weeks ]

Central Contacts

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