NCT07406438

To Evaluate the Safety, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

An Open-label, Multicenter, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd. · Network
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD. In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels. After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.

Detailed description

This is an open-label, multicenter, dose-escalating study in patients with nAMD. The study consists of two parts: single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD). It aims to evaluate the safety, tolerability, and PK/PD profile of single and multiple GB10 IVT injections in patients with nAMD, to investigate the efficacy of GB10, and to assess its immunogenicity. In SAD, a single IVT of 6 doses (per-eye administration, the same below) will be administered to up to 36 treatment-naïve or previously treated patients with neovascular age-related macular degeneration (nAMD). Participants will be enrolled sequentially, starting with the lowest dose and progressing to the highest. The first participant of each cohort will serve as the sentinel participant. If no dose-limiting toxicities related to GB10 treatment are observed among the participants, escalation will proceed to the next higher dose level after approval from the safety review committee. Two doses, best balancing efficacy and safety, will be determined in SAD and then entered into MAD. In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels. After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	GB10	GB10 Intravitreal Injection with indicating dosage.

Timeline

• Start date: 2026-02-12
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

6 sites across 1 country: China