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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: COR-1
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COR-1<br>single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 | Drug: COR-1<br>* single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1<br>* Other names: cyclic peptide;|
| Placebo Comparator: placebo<br>intravenous 0.9 % NaCl | Drug: placebo<br>* intravenous 0.9 % NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Reporting Adverse Events (AEs) | To assess the safety and tolerability of COR-1. | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-beta1 adrenergic receptor, autoantibody, cyclic peptide, heart failure