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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456828
• Other study ID #: ASKG712-CT-I-1
• Status: Recruiting
• Phase: Phase 1
• Start date: February 20, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2023
• Source: AskGene Pharma, Inc.
• Contact: Jing Chen, MD
• Phone: 086-15895835292
• Email: chenjing[@]ask-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
AskGene Pharma, Inc.	Suzhou Aosaikang Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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