NCT01043146

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

A Single-Blind Placebo-Controlled Dose Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of Cor-1, An Anti-ß1 Receptor Antibody Cyclopeptide, in Five Different Strengths in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Corimmun GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

Primary Trial objective: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration Secondary objectives: To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis) Methodology: Mono-center, single-blind, dose escalating study with five dose levels (8 subjects on verum per dose level, 2 subjects receiving placebo) in a total of 50 volunteers.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	COR-1	single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
DRUG	placebo	intravenous 0.9 % NaCl

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-01-06
• Last updated: 2013-04-08
• Results posted: 2013-04-08

Locations

1 site across 1 country: Germany