NCT04468997

The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD)

Phase I Clinical Trial of Recombinant Anti-VEGF Human Monoclonal Antibody in the Treatment of Wet Age-related Macular Degeneration

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Drug 601	Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
DRUG	Drug 601	Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;
DRUG	Drug 601	Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;
DRUG	Drug 601	Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
DRUG	Drug 601	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.
DRUG	Drug 601	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.

Timeline

• Start date: 2018-11-12
• Primary completion: 2021-03-15
• Completion: 2021-09-15
• First posted: 2020-07-13
• Last updated: 2020-07-13

Locations

1 site across 1 country: China