This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Jinan Central Hospital
Jinan, Shandong, China
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Measured in nanomoles\*hours per liter (nmol h/L).
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
Measured in nmol h/L.
Time frame: From Day 1 (pre-dose) until Day 7 (168 hours)
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Measured in nmol/L.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Measured in hours.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Measured in hours.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Measured in liters per hour (L/h).
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Measured in liters (L).
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in triglycerides
Measured in Percent change.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in high-density lipoprotein (HDL) cholesterol
Measured in Percent change.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in low-density lipoprotein (LDL) cholesterol
Measured in Percent change.
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
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