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

Phase 1

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: ASKG712

• Registration Number: NCT05456828
• Lead Sponsor: AskGene Pharma, Inc.

Brief Summary

The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) and multiple ascending-dose component (Part 2) 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.

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 Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-10
• Study First Posted: 2022-07-13
• Status Verified: 2023-02
• Study Start: 2023-02-20
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 30 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASKG712	ASKG712	Single or multiple ascending dose of ASKG712 by intravitreal injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Anti-Drug Antibody	Part 1: 6 weeks; Part 2: 20 weeks	To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Area under the concentration time curve (AUC)	Part 1: 6 weeks; Part 2: 20 weeks	To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
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	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
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	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Mean change from baseline in choroidal neovascularization area measured by fundus angiography	Part 1: 6 weeks; Part 2: 20 weeks	To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Maximum plasma concentration (Cmax)	Part 1: 6 weeks; Part 2: 20 weeks	To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China