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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-9961 | Other Identifier | World Health Organization (WHO) |
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This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC4004-0002 | Experimental | Participants will receive a single dose of NNC4004-0002 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts. |
|
| Placebo | Placebo Comparator | Participants in each cohort will receive placebo matched to NNC4004-0002 injected subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC4004-0002 | Drug | NNC4004-0002 will be given as a single ascending dose via subcutaneous route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent adverse event (TEAEs) | Count | From dosing (day 1) until end of study (approximately 28 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose | microgram•hour/mililiter (μg•h/mL) | From dosing (day 1) to 72 hours postdose |
| Cmax: The maximum concentration of NNC4004-0002 in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Glendale/LA EPCU | Not yet recruiting | Glendale | California | 91206 | United States | |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Placebo matched to NNC4004-0002 will be given via subcutaneous route. |
|
microgram/mililiter |
| From dosing (day 1) to 72 hours postdose |
| tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002 | Hours | From dosing (day 1) to 72 hours postdose |
| Renal clearance | Liter/hour (L/h) | From time of dose to 72 hours postdose |
| Changes in serum Uric Acid (sUA) over time | miligram/deciliter | From baseline through the end of the study (approximately 28 weeks) |
| PAREXEL Intl - EPCU-Baltimore |
| Recruiting |
| Baltimore |
| Maryland |
| 21225 |
| United States |