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

AskGene Pharma

Status and phase

Active, not recruiting

Phase 1

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Biological: ASKG712

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05456828

ASKG712-CT-I-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

56 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.