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).
Part 1 of this 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. Part 2 of this study was planned to be a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Part 2 was not initiated due to a strategic decision by the sponsor not related to safety or efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
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
Time frame: 24 weeks
Incidence of non-ocular AEs
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
Time frame: 24 weeks
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Time frame: 24 weeks
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Time frame: 24 weeks
Incidence of Anti-Drug Antibody (ADA)
To evaluate the immunogenicity of ASKG712 in patients with DME
Time frame: 24 weeks
Change From Baseline in BCVA in the Study Eye Over Time
To evaluate the efficacy of ASKG712 in patients with DME
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.