The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Administered via subcutaneous route
Administered via subcutaneous route
ICON - location Groningen
Groningen, Netherlands
Number of treatment emergent adverse events (TEAE) in cohorts 1 and 2
Number of events.
Time frame: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 15
Number of treatment emergent adverse events (TEAE) in cohort 3
Number of events.
Time frame: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 22
Number of treatment emergent adverse events (TEAE) in cohorts 4, 5 and 6
Number of events.
Time frame: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 40
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