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

2014-08-27 03:16:53 | BioPortfolio

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

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.

Study Design

Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Heart Failure

Intervention

COR-1, placebo

Location

Abx-Cro
Goerlitz
Saxonia
Germany
02826

Status

Completed

Source

Corimmun GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:53-0400

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