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NOT YET RECRUITING
NCT07406438
PHASE1

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

Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-02-12

Completion Date

2027-06-30

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

GB10

GB10 Intravitreal Injection with indicating dosage.

Locations (6)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Henan Provincial Eye Hospital

Zhengzhou, Henan, China

Nanchang University Second Affiliated Hospital

Nanchang, Jiangxi, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital (SRRSH), affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, China