Multicenter study to evaluate the safety and tolerability in patients with wet Age-related macular degeneration (wAMD) treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody
According to the results of preclinical pharmacological research and clinical application of bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the treatment of ocular diseases such as wAMD .Observe the safety and tolerability of the single and multiple doses of 601 in wAMD patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with wAMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;
BeiJing Hospital
Beijing, China
RECRUITINGDLT
Incidence of dose-limiting toxicities up to the Day 14 visit
Time frame: From Day 0 up to Day 14
MTD
Maximum tolerated dose
Time frame: From Day 0 up to Day 56/112.
Pharmacokinetic (PK) profile
Study the change of 601 drug concentration in the blood with time by mathematical principles and methods
Time frame: From Day 0 up to 56/112 days
Cmax
The maximum blood concentration after 601 drug enters the bloodstream
Time frame: From Day 0 up to 56/112 days
t1/2
The half-life of drug 601, the time required for the terminal phase 601 drug concentration to drop by half
Time frame: From Day 0 up to 56/112 days
AUC
Area under the concentration-time curve, reflect the characteristics of the exposure of 601 drug in the body.
Time frame: From Day 0 up to 56/112 days
Vd
The proportional constant between the amount of 601 drug in the body and the blood concentration when the 601 drug achieves the dynamic balance in the body.
Time frame: From Day 0 up to 56/112 days
CL
Clearance rate of drug 601 from the central ventricle.
Time frame: From Day 0 up to 56/112 days
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Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
MRT
The average length of time that the 601 drug stays in the body.
Time frame: From Day 0 up to 56/112 days
λz
the ratio of the amount of elimination of 601 drug from the body per unit time to the total amount in the body
Time frame: From Day 0 up to 56/112 days
Biomarker
Detection of VEGF concentration.
Time frame: From Day 0 up to 56/112 days
Immunogenicity
Development of Anti-drug antibodies (ADA) after IVT injection of 601
Time frame: From Day 0 up to 56/112 days
CRT
Changes in central retina thickness (CRT) at all time points compared to the baseline
Time frame: From Day 0 up to 56/364 days
diseased region
Changes in the diseased region at all time points compared to the baseline
Time frame: From Day 0 up to 56/364 days