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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corimmun GmbH
• Treatments: Antibodies

Criteria

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