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

NCT ID: NCT05456828

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2025-12-31

Brief Summary

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).

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASKG712

Single or multiple ascending dose of ASKG712 by intravitreal injection

Group Type: EXPERIMENTAL

ASKG712

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

AM712

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Aosaikang Biopharmaceutical Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

AskGene Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kun Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ASKG712-CT-I-1

Identifier Type: -

Identifier Source: org_study_id