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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1274-4316 | Other Identifier | World Health Organization (WHO) | |
| 2022-001813-38 | EudraCT Number | ||
| 2023-506928-83 | Registry Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose 1: NNC0582-0001 10 milligram (mg) | Experimental | Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously. |
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| Single Dose 2: NNC0582-0001 30 mg | Experimental | Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously. |
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| Single Dose 3: NNC0582-0001 90 mg | Experimental | Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously. |
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| Single Dose 4: NNC0582-0001 250 mg | Experimental | Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously. |
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| Single Dose 5: NNC0582-0001 600 mg | Experimental | Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0582-0001 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From dosing (Day 1) until End of Study visit (Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From dosing (Day 1) to 168 hours after dosing |
| Cmax: The maximum concentration of NNC0582-0001 in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Unit / Center for Medical Research | Graz | 8010 | Austria |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| Single Dose 6: NNC0582-0001 1000 mg | Experimental | Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously. |
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| Placebo | Drug | Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001. |
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Measured in nanogram per mililiter (ng/mL). |
| 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. | From dosing (Day 1) to 168 hours after dosing |