Clinical Trial: Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single-Blind Placebo-Controlled Dose Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of Cor-1, An Anti-ß1 Receptor Antibody Cyclo
Brief 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 Summary:
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.
Sponsor: Corimmun GmbH
Current Primary Outcome: The Number of Participants Reporting Adverse Events (AEs) [ Time Frame: 45 days ]
Original Primary Outcome: pharmacokinetics and -dynamics [ Time Frame: 45 days ]
Current Secondary Outcome:
Original Secondary Outcome: safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate, 12 lead ECG, antibody titers and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis) [ Time Frame: 45 days ]
Information By: Corimmun GmbH
Dates:
Date Received: January 5, 2010
Date Started: October 2009
Date Completion:
Last Updated: March 5, 2013
Last Verified: March 2013