NCT03725566

JY028 Single Vitreous Injection in a Phase 1 Clinical Trial in nAMD Patients

Phase I Clinical Trial of Recombinant Humanized Anti-vegf Monoclonal Antibody Single Vitreous Injection for Safety, Tolerance, PK and Pharmacodynamics in nAMD Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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;

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Experimental	Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;

Timeline

• Start date: 2018-05-22
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-10-31
• Last updated: 2018-10-31

Locations

1 site across 1 country: China