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

NCT07406438 | Not Yet Recruiting Phase 1

• 1 other identifier: KXZY-GB10-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

nAMD; GB10; PK/PD

Outcome Measures

Primary Outcomes (4)

• The incidence and severity of ocular adverse events

  From enrollment to the end of treatment at 12 weeks

• The incidence and severity of non-ocular adverse events

  From enrollment to the end of treatment at 12 weeks

• (SAD) The change in best corrected visual acuity (BCVA) from baseline after 4 weeks of treatment

  From enrollment to the end of treatment at 4 weeks

• (MAD) The change in best corrected visual acuity (BCVA) from baseline after 12 weeks of treatment

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (12)

• (SAD) Change in central retinal subfield thickness (CST) from baseline at 4 weeks of treatment

  From enrollment to the end of treatment at 4 weeks

• (MAD) Change in central retinal subfield thickness (CST) from baseline at 12 weeks of treatment

  From enrollment to the end of treatment at 12 weeks

• Time of receiving rescue therapy for nAMD activity

  From enrollment to the end of treatment at 12 weeks

• Positive rate of anti-drug antibody and neutralizing antibody of GB10

  From enrollment to the end of treatment at 12 weeks

• Area under the drug-time curve from 0 to time t of GB10

  From enrollment to the end of treatment at 12 weeks

Study Arms (8)

SAD Dose 1

EXPERIMENTAL

SAD Dose 1 IVT

Drug: GB10

SAD Dose 2

EXPERIMENTAL

SAD Dose 2 IVT

Drug: GB10

SAD Dose 3

EXPERIMENTAL

SAD Dose 3 IVT

Drug: GB10

SAD Dose 4

EXPERIMENTAL

SAD Dose 4 IVT

Drug: GB10

SAD Dose 5

EXPERIMENTAL

SAD Dose 5 IVT

Drug: GB10

SAD Dose 6

EXPERIMENTAL

SAD Dose 6 IVT

Drug: GB10

MAD Dose 1

EXPERIMENTAL

MAD Dose 1 IVT

Drug: GB10

MAD Dose 2

EXPERIMENTAL

MAD Dose 2 IVT

Drug: GB10

Interventions

GB10 DRUG

GB10 Intravitreal Injection with indicating dosage.

MAD Dose 1; MAD Dose 2; SAD Dose 1; SAD Dose 2; SAD Dose 3; SAD Dose 4; SAD Dose 5; SAD Dose 6

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred \> 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).
• The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);
• CNV lesion of all types (CNV lesion types in the study eye include predominantly classic, minimally classic, or occult \[including polypoidal choroidal vasculopathy (PCV)\]) with:
• Total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas by FFA;
• CNV component area of ≥ 50% of total lesion size by FFA;
• Active CNV confirmed by FFA (evidence of leakage);
• CNV exudation confirmed by SD-OCT (presence of fluid).
• BCVA letter score in the study eye of 78-24 letters (inclusive) in ETDRS-like charts (20/32-20/320 Snellen equivalent) before the first dose;
• Willingness to participate in the study, to comply with the study protocol, and to provide signed informed consent.

You may not qualify if:

• CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;
• The study eye on FFA:
• Subretinal hemorrhage of \> 50% of the total lesion area and/or that involves the fovea; or
• Fibrosis or atrophy of \> 50% of the total lesion area and/or that involves the fovea;
• Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy \[CSC\], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;
• Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in the study eye (for study eye with prior refractive surgery or cataract surgery, preoperative refractive error demonstrating more than 8 diopters), or axial length \>26.5 mm when reliable refractive assessment is unavailable;
• Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as IOP≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye;
• Current or prior receipt of any treatment for the study eye, including but not limited to:
• IVT implantation or injection other than anti-VEGF drugs within 6 months before screening (e.g., steroids, transplasminogen activator, ocriplasmin, C₃F₈ gas, air filling);
• Periocular pharmacological interventions for retinal diseases within 6 months before screening (including subconjunctival, sub-tenon's, peribulbar, or retrobulbar injections);
• Laser/photodynamic therapies within 6 months before screening (including laser photocoagulation, verteporfin PDT, diode laser, or transpupillary thermotherapy);
• Cataract surgery within 3 months before screening, or corticosteroid treatment for complications of cataract surgery, or YAG (yttrium aluminum garnet) laser posterior capsulotomy;
• Prior other intraocular surgery (e.g., pars plana vitrectomy \[PPV\], glaucoma surgery \[except YAG peripheral iridotomy \>3 months prior\], corneal transplant, or radiotherapy).
• Active intraocular inflammation (grade trace or above) in the study eye before the first dose;
• Current vitreous hemorrhage (grade trace or above) in the study eye before the first dose;

Sponsors & Collaborators

• Shenzhen Kexing Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

Henan Provincial Eye Hospital

Zhengzhou, Henan, 450015, China

Location

Nanchang University Second Affiliated Hospital

Nanchang, Jiangxi, 330006, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Central Study Contacts

Hengxin Peng

CONTACT

86-0755-23018589; penghengxin@kexing.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: nAMD

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 12, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)