In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
Healthy volunteers will receive one injection s.c.
Novo Nordisk Investigational Site
Harrow, United Kingdom
Number of treatment emergent adverse events (TEAEs)
Count
Time frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
AUC0-∞,0434,SD; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to infinity after a single dose of s.c. NNC0385-0434
nmol/L\*h
Time frame: From day of dose (Day 1) until end of treatment (Day 70)
Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434
nmol/L
Time frame: From day of dose (Day 1) until end of treatment (Day 70)
t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434
h
Time frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
tmax,0434,SD; the time to maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434
h
Time frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434
Ratio to pre-dose
Time frame: Day 1, day 70
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