This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Clinical Trials Unit / Center for Medical Research
Graz, Austria
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From dosing (Day 1) until End of Study visit (Week 52)
AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.
Measured in hours \* nanogram per mililiter (h\*ng/mL).
Time frame: From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0582-0001 in plasma
Measured in nanogram per mililiter (ng/mL).
Time frame: From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001
Measured in hours.
Time frame: From dosing (Day 1) to 168 hours after dosing
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