Conditions: Heart Failure
Keywords: anti-beta1 adrenergic receptor autoantibody cyclic peptide heart failure
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: yes

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 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.

Arms:
arm 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 arm 2: intravenous 0.9 % NaCl

Interventions: intervention 1: COR-1 intervention 2: placebo
Intervention descriptions: intervention 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 intervention 2: intravenous 0.9 % NaCl

Protocol document: