About this trial
This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female (sex at birth).
Age 18-55 years (both inclusive) at the time of signing the informed consent.
Body mass index 18.5-29.9 kilograms per square metre (kg/m²) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.
Disqualifiers
Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
Alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) +10 percentage (%)
Aspartate aminotransferase (AST) >ULN +20%
Bilirubin >ULN +20%
Trial design
Crossover
Treatments tested in this trial
CDR132L (i.v.)
DrugCDR132L will be administered intravenously.
CDR132L (s.c.)
DrugCDR132L will be administered subcutaneously.
Treatment groups
Trial outcomes
Primary outcomes
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
Measured as hours\*nanograms per milliliter (h\*ng/mL)
Secondary outcomes
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Measured as h\*ng/mL
Maximum observed CDR132L plasma concentration after a single dose
Measured as nanograms per milliliter (ng/mL)
Time to maximum observed CDR132L plasma concentration after a single dose
Measured in hours
Terminal half-life for CDR132L after a single dose
Measured in hours
Sponsors and contacts
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