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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ASKG712
Sponsored by
AskGene Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASKG712

Arm Description

Single or multiple ascending dose of ASKG712 by intravitreal injection

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Anti-Drug Antibody
To evaluate the immunogenicity 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
To evaluate the efficacy 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)
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
To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)

Full Information

First Posted
July 6, 2022
Last Updated
February 26, 2023
Sponsor
AskGene Pharma, Inc.
Collaborators
Suzhou Aosaikang Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05456828
Brief Title
A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AskGene Pharma, Inc.
Collaborators
Suzhou Aosaikang Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASKG712
Arm Type
Experimental
Arm Description
Single or multiple ascending dose of ASKG712 by intravitreal injection
Intervention Type
Biological
Intervention Name(s)
ASKG712
Other Intervention Name(s)
AM712
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of ocular adverse events (AEs) of the study eyes
Description
Any relevant ocular observations assessed by best corrected visual acuity (BCVA) , slitlamp examination, ophthalmoscopy, intraocular pressure, fundus photography, optical coherence tomography (OCT) and angiography
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Incidence of non-ocular adverse events (AEs)
Description
Any changes of clinical safety observations assessed by vital signs, electrocardiograph (ECG), clinical laboratory tests and physical examination
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Secondary Outcome Measure Information:
Title
Area under the concentration time curve (AUC)
Description
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Maximum plasma concentration (Cmax)
Description
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Anti-Drug Antibody
Description
To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Mean change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score
Description
To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Mean change from baseline in central subfield thickness (CST) of macula measured by optical coherence tomography (OCT)
Description
To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks
Title
Mean change from baseline in choroidal neovascularization area measured by fundus angiography
Description
To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)
Time Frame
Part 1: 6 weeks; Part 2: 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Chen, MD
Phone
086-15895835292
Email
chenjing@ask-pharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luwei Han, PhD
Phone
086- 15195873396
Email
hanluwei@ask-pharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Liu, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Liu, MD
Email
drxuxun@sjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xun Xu, MD
Email
drliukun@sjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD or supporting information available.

Learn more about this trial

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

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