Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-14 @ 2:16 AM
Study NCT ID:
NCT05456828
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-10', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ocular adverse events (AEs) of the study eyes', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks', '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'}, {'measure': 'Incidence of non-ocular adverse events (AEs)', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks', 'description': 'Any changes of clinical safety observations assessed by vital signs, electrocardiograph (ECG), clinical laboratory tests and physical examination'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration time curve (AUC)', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks', 'description': 'To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks', 'description': 'To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}, {'measure': 'Anti-Drug Antibody', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks', 'description': 'To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}, {'measure': 'Mean change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks', 'description': 'To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}, {'measure': 'Mean change from baseline in central subfield thickness (CST) of macula measured by optical coherence tomography (OCT)', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks', 'description': 'To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}, {'measure': 'Mean change from baseline in choroidal neovascularization area measured by fundus angiography', 'timeFrame': 'Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks', 'description': 'To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degenerationn (nAMD)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Signed the informed consent form;\n* 2\\. Male or female subjects with 50\\~80 years of age;\n* 3\\. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesions secondary to neovascular age-related macular degeneration(nAMD);\n* 4\\. Total lesion area ≤ 12 disc area(DA);\n* 5\\. BCVA letter score measured at screening of 19\\~78 letters.\n\nExclusion Criteria:\n\n* 1\\. History of uveitis in either eye；\n* 2\\. Current active inflammation or infection in the study eye;\n* 3\\. Central foveal scar, fibrosis or atrophy of macular in the study eye;\n* 4\\. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;\n* 5\\. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;\n* 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.\n* 7\\. Presence of retinal pigment epithelial tear;\n* 8\\. Previous intraocular operations in the study eye;\n* 9\\. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;\n* 10\\. Previous anti-VEGF drug treatment within 60 days prior to screening；\n* 11\\. Diseases that affect intravenous injection and venous blood sampling;\n* 12\\. Systemic autoimmune diseases;\n* 13\\. Any uncontrolled clinical disorders;\n* 14\\. History of allergy or current allergic response to ASKG712 or fluorescein;\n* 15\\. Pregnant or nursing women;\n* 16\\. Subjects should be excluded in the opinion of investigators.'}, 'identificationModule': {'nctId': 'NCT05456828', 'briefTitle': 'A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'AskGene Pharma, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ASKG712-CT-I-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASKG712', 'description': 'Single or multiple ascending dose of ASKG712 by intravitreal injection', 'interventionNames': ['Biological: ASKG712']}], 'interventions': [{'name': 'ASKG712', 'type': 'BIOLOGICAL', 'otherNames': ['AM712'], '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.', 'armGroupLabels': ['ASKG712']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Kun Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD or supporting information available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AskGene Pharma, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Suzhou Aosaikang Biopharmaceutical Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}