A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration

A Multi-Center, Open-label, Single Ascending-Dose and Multiple Ascending-Dose Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Neovascular Age-related Macular Degeneration

The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) , multiple ascending-dose component (Part 2) and multiple-dose extension component (Part 3) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).

Study Overview

• Status: Active, not recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Biological: ASKG712

Detailed Description

The Part 1 of study is a multicenter, open-label, sequentially, single ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

The Part 2 of study is a multicenter, open-label, sequentially, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

The Part 3 of study is a multicenter, open-label, randomized, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD at 2 recommanded dose levels.

Subjects will be sequentially enrolled into different dose-level cohorts following the "3+3" design to determine the maximum tolerated dose (MTD) or the maximum administered dose has been reached.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Signed the informed consent form;
• 2. Male or female subjects with 50~80 years of age;
• 3. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesions secondary to neovascular age-related macular degeneration(nAMD);
• 4. Total lesion area ≤ 12 disc area(DA);
• 5. BCVA letter score measured at screening of 19~78 letters.

Exclusion Criteria:

• 1. History of uveitis in either eye；
• 2. Current active inflammation or infection in the study eye;
• 3. Central foveal scar, fibrosis or atrophy of macular in the study eye;
• 4. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
• 5. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
• 6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of ASKG712 or require medical or surgical intervention.
• 7. Presence of retinal pigment epithelial tear;
• 8. Previous intraocular operations in the study eye;
• 9. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
• 10. Previous anti-VEGF drug treatment within 60 days prior to screening；
• 11. Diseases that affect intravenous injection and venous blood sampling;
• 12. Systemic autoimmune diseases;
• 13. Any uncontrolled clinical disorders;
• 14. History of allergy or current allergic response to ASKG712 or fluorescein;
• 15. Pregnant or nursing women;
• 16. Subjects should be excluded in the opinion of investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASKG712; Single or multiple ascending dose of ASKG712 by intravitreal injection	Biological: ASKG712; ASKG712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.; Other Names: AM712

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ocular adverse events (AEs) of the study eyes	Any relevant ocular observations assessed by best corrected visual acuity (BCVA) , slitlamp examination, ophthalmoscopy, intraocular pressure, fundus photography, optical coherence tomography (OCT) and angiography	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
Incidence of non-ocular adverse events (AEs)	Any changes of clinical safety observations assessed by vital signs, electrocardiograph (ECG), clinical laboratory tests and physical examination	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration time curve (AUC)	To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Maximum plasma concentration (Cmax)	To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Anti-Drug Antibody	To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Mean change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
Mean change from baseline in central subfield thickness (CST) of macula measured by optical coherence tomography (OCT)	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
Mean change from baseline in choroidal neovascularization area measured by fundus angiography	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)	Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

Collaborators and Investigators

• Sponsor: AskGene Pharma, Inc.
• Collaborators: Suzhou Aosaikang Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kun Liu, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: ASKG712-CT-I-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD or supporting information available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No