At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
COR-1 +1 moredrug
Likely dose
COR-1 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating COR-1 and placebo for Heart Failure. Completed, enrolled 50 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
Primary CompletionJan 2010
First PostedJan 2010
TodayJul 2026
First PostedJan 6, 2010
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.5 years ago
Interventions
COR-1drug
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
placebodrug
intravenous 0.9 % NaCl