Phase 1 Completed N=50 Single-blind Treatment

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

Heart Failure

Source: ClinicalTrials.gov NCT01043146 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Apr 2013

Primary outcomePrimary: The Number of Participants Reporting Adverse Events (AEs) — 0; 0; 3; 0 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants Reporting Adverse Events (AEs)	0; 0; 3; 0; 0; 0	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01043146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.