Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGNNC0582-0001
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.
DRUGPlacebo
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * 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, as judged by the investigator.
Exclusion criteria
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole \[mmol/mol\]) at screening. * Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From dosing (Day 1) until End of Study visit (Week 52) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose. | From dosing (Day 1) to 168 hours after dosing | Measured in hours \* nanogram per mililiter (h\*ng/mL). |
| Cmax: The maximum concentration of NNC0582-0001 in plasma | From dosing (Day 1) to 168 hours after dosing | Measured in nanogram per mililiter (ng/mL). |
| tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001 | From dosing (Day 1) to 168 hours after dosing | Measured in hours. |
Countries
Austria
Outcome results
None listed