NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

Summary

The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.

Timeline

Start

2010-07

Primary completion

2012-02

Completion

2012-02

Publications

• Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

Drugs

Indications