Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Sponsor
Benobio Co., Ltd.
Study ID
NCT05803785
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBC1501 — DRUG
    BBC1501 solution for Intravitreal injection

Study Details

This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.

Key Dates

First listed
Apr 7, 2023
Start date
Jul 1, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BBC1501 1.25ug
    Cohort 1; open-label, non-randomized, single administration
  • Experimental: BBC1501 2.5ug
    Cohort 2; open-label, non-randomized, single administration
  • Experimental: BBC1501 5ug
    Cohort 3; open-label, non-randomized, single administration

Primary Outcome Measure

Assessment of ophthalmic and systemic TEAEs, during study period [ Time Frame: Every week up to 4 weeks ]

Central Contacts

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