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

Corimmun GmbH50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Heart Failure

Interventions

COR-1DRUG

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

placeboDRUG

intravenous 0.9 % NaCl

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ABX-CRO

Görlitz, Saxony, Germany

Outcomes

Primary Outcomes

The Number of Participants Reporting Adverse Events (AEs)

To assess the safety and tolerability of COR-1.

Time frame: 45 days

Data from ClinicalTrials.gov

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