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

NCT05456828 | Active Not Recruiting Phase 1

• 1 other identifier: ASKG712-CT-I-1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Area under the concentration time curve (AUC)

  Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

• Maximum plasma concentration (Cmax)

  Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

• Anti-Drug Antibody

  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

  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)

  Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

Study Arms (1)

ASKG712

EXPERIMENTAL

Single or multiple ascending dose of ASKG712 by intravitreal injection

Biological: ASKG712

Interventions

ASKG712 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.

Also known as: AM712

ASKG712

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \. History of uveitis in either eye；
• \. Current active inflammation or infection in the study eye;
• \. Central foveal scar, fibrosis or atrophy of macular in the study eye;
• \. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
• \. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
• \. 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.
• \. Presence of retinal pigment epithelial tear;
• \. Previous intraocular operations in the study eye;
• \. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
• \. Previous anti-VEGF drug treatment within 60 days prior to screening；
• \. Diseases that affect intravenous injection and venous blood sampling;
• \. Systemic autoimmune diseases;
• \. Any uncontrolled clinical disorders;
• \. History of allergy or current allergic response to ASKG712 or fluorescein;
• \. Pregnant or nursing women;

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Suzhou Aosaikang Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Kun Liu, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 13, 2022
• Study Start: February 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)