Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration

Phase 1 Completed 12 enrolled RemeGen Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start: 2019-01-07
Primary completion: 2019-08-20
Completion: 2019-08-20

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RC28-E	Protein / enzyme biologic	0.25 mg	Intravitreal
Subject	RC28-E	Protein / enzyme biologic	0.5 mg	Intravitreal
Subject	RC28-E	Protein / enzyme biologic	1 mg	Intravitreal
Subject	RC28-E	Protein / enzyme biologic	2 mg	Intravitreal

Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration

Summary

Timeline

Publications

Drugs

Indications