Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide (COR-1-01)

Corimmun

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: COR-1; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043146

EudraCT2008-007745-31 (Registry Identifier)

COR-1-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, male Caucasians between 18 and 45 years of age, inclusive
• Normotensive subjects (systolic BP <140 mmHg and diastolic BP <90 mmHg)
• Body mass index (BMI) 19-27, minimal weight 60 kg
• Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests, and negative result in anti-ß1-receptor-autoantibody screening
• Signed Informed Consent Form
• Normal or clinically irrelevant laboratory findings

Exclusion criteria

• Autoimmune disorders
• Kidney diseases
• Liver diseases, liver function impairments

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

COR-1

Active Comparator group

Description:

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

Treatment:

Drug: COR-1

placebo

Placebo Comparator group

Description:

intravenous 0.9 % NaCl

Treatment:

Drug: placebo