Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
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
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)
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
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)
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.
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
intravenous 0.9 % NaCl
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
|Event Type||Organ System||Event Term||Placebo||10 mg COR-1||40 mg COR-1||80 mg COR-1||160 mg COR-1||240 mg COR-1|
To assess the safety and tolerability of COR-1.