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Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma

Open-angle Glaucoma Clinical Trial

Official title:
A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma

Clinical Trial Summary

This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

Clinical Trial Description

This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03488550
Study type Interventional
Source Annexon, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 23, 2018
Completion date August 3, 2018
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