Phase I clinical trial on safety, tolerance, pharmacokinetics (PK) and pharmacodynamics of recombinant human anti-VEGF monoclonal antibody injection in patients with neovascular (wet) age-related macular degeneration
Test drug:Recombinant humanized anti VEGF monoclonal antibody injection; Research Phase:Phase I; Subjects:Subjects with neovascular (wet) age-related macular degeneration; Number of Subjects:24; Trial design:Single center, non randomized, open, single arm, single dose, dose escalation; Research objective:to rearch the safety and tolerance of JY028 injection;to rearch PK of JY028 injection;to observe the efficacy of JY028 in the treatment of nAMD;to rearch the relationship between plasma VEGF concentration and JY028 concentration. to rearch immunogenicity of JY028;
Study Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
24
Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
JY028 related incidence of ocular and systemic adverse events and serious adverse events
JY028 related incidence of ocular and systemic adverse events and serious adverse events
Time frame: 13 weeks
Cmax
Maximum blood drug concentration
Time frame: 13 weeks
Tmax
Peak time of blood drug concentration
Time frame: 13 weeks
BCVA
The best corrected visual acuity change
Time frame: 13 weeks
AUC0-t、AUCinf
The area under the plasma concentration time curves
Time frame: 13 weeks
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