Title
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
Phase
Phase 1Lead Sponsor
Corimmun GmbHStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Heart FailureIntervention/Treatment
cor-1 ...Study Participants
50Primary 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.
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.
