Worsening Heart Failure
Conditions
Brief summary
The primary endpoints are the individual assessments of the dose-effect relationship of COR-1167 on: • Natriuresis • Body weight • NT-proBNP • KCCQ-TSS • LAVi
Detailed description
Safety and tolerability of 3 s.c. o.d. doses of COR-1167, as assessed by the following parameters: o Clinical safety laboratory parameters (hematology, chemistry, coagulation, urinalysis, eGFR) o Vital signs (blood pressure, heart rate, respiratory rate, and body temperature) o Physical examinations o 12-lead electrocardiogram (ECG) o Adverse events (AEs), Anti-drug antibody (ADA) semi-quantitative determination after 28-day treatment with COR-1167
Interventions
DRUGPlacebo solution for injection matching COR-1167
DRUGCOR-1167
Sponsors
Corteria Pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the individual assessments of the dose-effect relationship of COR-1167 on: • Natriuresis • Body weight • NT-proBNP • KCCQ-TSS • LAVi | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of 3 s.c. o.d. doses of COR-1167, as assessed by the following parameters: o Clinical safety laboratory parameters (hematology, chemistry, coagulation, urinalysis, eGFR) o Vital signs (blood pressure, heart rate, respiratory rate, and body temperature) o Physical examinations o 12-lead electrocardiogram (ECG) o Adverse events (AEs), Anti-drug antibody (ADA) semi-quantitative determination after 28-day treatment with COR-1167 | — |
Countries
Czechia, Hungary, Poland, Romania, Spain
Outcome results
None listed