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Healthy Other

A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia

Locations

United States

Start date

13/11/2024

Identifiers

Trial ID NN4004-8071,
NCT number NCT06859073,
Eudract number Not Available

Summary

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.

Trial Overview:

Condition

Healthy Volunteers

Hyperuricemia

Treatment

DRUG: NNC4004-0002

DRUG: Placebo

Study type

INTERVENTIONAL

Trial duration

Nov 13 2024 - May 19 2026

Participants

60

Phase

I

Are you eligible?

Gender

FEMALE

Age

35 to 75 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

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