Back to resultsA Study of ASKG712 in Patients With Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ASKG712
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of diabetes mellitus (Type 1 or Type 2) Hemoglobin A1c of less than or equal to 12% For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment Ability and willingness to undertake all scheduled visits and assessments Macular thickening secondary to DME involving the center of the fovea Decreased visual acuity attributable primarily to DME Exclusion Criteria: History of allergy or current allergic response to ASKG712 or fluorescein Diseases that affect intravenous injection and venous blood sampling Uncontrolled blood pressure Systemic autoimmune diseases Previous anti-VEGF drug treatment Currently pregnant or breastfeeding, or intend to become pregnant during the study Any uncontrolled clinical disorders Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye History of intraocular or periocular corticosteroid treatment in the study eye Uncontrolled previous or current glaucoma in the study eye Previous intraocular operations in the study eye Active intraocular or periocular infection or active intraocular inflammation in the study eye History of uveitis in either eye Other protocol-specified inclusion/exclusion criteria may apply
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASKG712
Arm Description
Multiple doses of ASKG712 by intravitreal injection
Outcomes
Primary Outcome Measures
1. Incidence of ocular adverse events (AEs) of the study eyes
Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography
2. Incidence of non-ocular AEs
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
Secondary Outcome Measures
1. Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
2. Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
3. Incidence of Anti-Drug Antibody (ADA)
To evaluate the immunogenicity of ASKG712 in patients with DME
4. Change From Baseline in BCVA in the Study Eye Over Time
To evaluate the efficacy of ASKG712 in patients with DME
Full Information
NCT ID
NCT05940428
First Posted
May 11, 2023
Last Updated
July 12, 2023
Sponsor
AskGene Pharma, Inc.
Collaborators
Suzhou Aosaikang Biopharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05940428
Brief Title
A Study of ASKG712 in Patients With Diabetic Macular Edema
Official Title
A Multicenter, Non-Randomized, Open-Label, Multiple-Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).
Detailed Description
The Part 1 of study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.
The Part 2 of study is a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASKG712
Arm Type
Experimental
Arm Description
Multiple doses 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
1. Incidence of ocular adverse events (AEs) of the study eyes
Description
Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography
Time Frame
24 weeks
Title
2. Incidence of non-ocular AEs
Description
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
1. Area under the concentration time curve (AUC)
Description
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Time Frame
24 weeks
Title
2. Maximum plasma concentration (Cmax)
Description
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Time Frame
24 weeks
Title
3. Incidence of Anti-Drug Antibody (ADA)
Description
To evaluate the immunogenicity of ASKG712 in patients with DME
Time Frame
24 weeks
Title
4. Change From Baseline in BCVA in the Study Eye Over Time
Description
To evaluate the efficacy of ASKG712 in patients with DME
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
Hemoglobin A1c of less than or equal to 12%
For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment
Ability and willingness to undertake all scheduled visits and assessments
Macular thickening secondary to DME involving the center of the fovea
Decreased visual acuity attributable primarily to DME
Exclusion Criteria:
History of allergy or current allergic response to ASKG712 or fluorescein
Diseases that affect intravenous injection and venous blood sampling
Uncontrolled blood pressure
Systemic autoimmune diseases
Previous anti-VEGF drug treatment
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Any uncontrolled clinical disorders
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
History of intraocular or periocular corticosteroid treatment in the study eye
Uncontrolled previous or current glaucoma in the study eye
Previous intraocular operations in the study eye
Active intraocular or periocular infection or active intraocular inflammation in the study eye
History of uveitis in either eye
Other protocol-specified inclusion/exclusion criteria may apply
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
Youxin Chen, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youxin Chen, MD
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 Diabetic Macular Edema
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