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Multicenter ,open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody(SCT510A)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT510A dose level 1 treatment | Experimental | SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks,three times continuously |
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| SCT510A dose level 2 treatment | Experimental | SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks,three times continuously |
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| SCT510A dose level 3 treatment | Experimental | SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks,three times continuously |
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| SCT510A dose level 4 treatment | Experimental | SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks,three times continuously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT510A | Drug | SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting toxicity(DLT) | Incidence of dose-limiting toxicities up to the Day 14 visit | From Day 0 up to Day 14 |
| Maximum tolerated dose(MTD) | Maximum tolerated dose | From Day 0 up to Day 140 |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile | Change of SCT510A drug concentration in the blood with time | From Day 0 up to 84 days |
| Cmax | The maximum blood concentration after SCT510A drug enters the bloodstream |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Guo | Contact | +86-10-58628288-9138 | ming_guo@sinocelltech.com |
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| From Day 0 up to 84 days |
| Tmax | Time to the Maximum Concentration of SCT510A | From Day 0 up to 84 days |
| t1/2 | Elimination Phase Half-life of SVT510A | From Day 0 up to 84 days |
| Biomarker | Detection of free VEGF concentration | From Day 0 up to 84 days |
| Immunogenicity | Positive rate of ADA and NAb | From Day 0 up to 112 days |
| central retina thickness(CRT) | Changes in CRT compared to the baseline | From Day 0 up to 140 days |
| Macular edema volume | Changes in Macular edema volume compared to the baseline | From Day 0 up to 140 days |
| Best corrected visual acuity(BCVA) | Changes in BCVA compared to the baseline | From Day 0 up to 140 days |