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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
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
Time frame: 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
Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)
Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)
Time frame: 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)
Time frame: 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)
Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
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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)
Time frame: 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)
Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks