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| Name | Class |
|---|---|
| Suzhou Aosaikang Biopharmaceutical Co., Ltd. | UNKNOWN |
| AskGene Pharma, Inc. | INDUSTRY |
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The purpose of the Phase 1/2a 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).
Part 1 of the study is a multicenter, open-label, sequential, single ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.
Part 2 of the study is a multicenter, open-label, sequential, multiple ascending-dose (3 loading doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.
Part 3 of the study is a Phase 2a, multicenter, open-label, randomized, multiple ascending-dose (3 loading doses) expansion study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the 3.0 mg and 6.0 mg doses of ASKG712 in subjects with nAMD.
For Parts 1 and 2, 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. For Part 3 subjects will be randomized 2:1 to the 6.0mg and 3.0mg dose arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASKG712 | Experimental | Single or multiple ascending dose of ASKG712 by intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASKG712 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular adverse events (AEs) of the study eyes | Any relevant ocular observations assessed by best corrected visual acuity (BCVA), slit lamp examination, ophthalmoscopy, intraocular pressure, fundus photography, optical coherence tomography (OCT) and angiography | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks |
| 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; Part 3: up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) | To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD) | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks |
| Maximum plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun Liu, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
There is no plan to make IPD or supporting information available.
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To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD) |
| Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks |
| Anti-Drug Antibody | To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD) | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks |
| 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 degeneration (nAMD) | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks |
| 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 degeneration (nAMD) | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks |
| 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 degeneration (nAMD) | Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks |