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The purpose of this first-in-human study is to evaluate the safety, tolerability and pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in subjects with wet age-related macular degeneration (wAMD).
This is an open-label, non-randomized,double-center phase 1 study evaluating pharmacokinetics, safety and tolerability of single intravitreal injections of RC28-E in the patients with AMD.RC28-E is recombinant dual decoy receptor IgG1 Fc-fusion protein,can block VEGF-A and FGF-2. In preclinical studies suggested that RC28-E might be more effective in inhibiting pathological angiogenesis than other VEGF antagonists on CNV. Every subject will only accept one dose. In addition to safety and preliminary efficacy, pharmacokinetics and immunogenicity of RC28-E will be evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC28-E | Experimental | "·Experimental:RC28-E 0.25mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC28-E | Biological | RC28-E intravitreous injection 50ul |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular and systemic adverse events and serious adverse events which are related to RC28-E | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve(AUC) | 42 days | |
| Maximum observed maximum plasma concentration (Cmax) | 42 days | |
| Time to reach the maximum observed plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| wenbin wei | BEIJING TONGREN HOSPITAL.CMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital .Cmu | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31652997 | Derived | Kou X, Sun Y, Li S, Bian W, Liu Z, Zhang D, Jiang J. Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. Biomolecules. 2019 Oct 24;9(11):644. doi: 10.3390/biom9110644. |
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| 42 days |
| T1/2(Terminal phase half life after single dose) | 42 days |
| Change in Best Corrected Visual Acuity (BCVA) from baseline | 42 days |
| Change in Central Retinal Thickness(CRT)from baseline | 42 days |
| ID | Term |
|---|---|
| C000710674 | RC28-E protein |
| D016222 | Fibroblast Growth Factor 2 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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