drugset / Trial / NCT03790852

Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

NCT03790852

Phase 1 Terminated 121 enrolled Kodiak Sciences Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg

Timeline

Start
2018-12-26
Primary completion
2021-06-02
Completion
2022-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Tarcocimab tedromer Protein / enzyme biologic 2.5 mg Intravitreal
Subject Tarcocimab tedromer Protein / enzyme biologic 5 mg Intravitreal