Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide

Summary

Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo) Secondary objectives: To evaluate safety and tolerability by using adverse events (AEs) and vital signs

Timeline

Start

2009-10

Primary completion

2010-01

Completion

2010-01

Publications

• Munch G, Boivin-Jahns V, Holthoff HP, Adler K, Lappo M, Truol S, Degen H, Steiger N, Lohse MJ, Jahns R, Ungerer M. Administration of the cyclic peptide COR-1 in humans (phase I study): ex vivo measurements of anti-beta1-adrenergic receptor antibody neutralization and of immune parameters. Eur J Heart Fail. 2012 Nov;14(11):1230-9. doi: 10.1093/eurjhf/hfs118. Epub 2012 Sep 11.

Drugs

Indications