Phase 1 Study to Evaluate the Safety of Single Doses of NNC4004-0002 Injection in Adults Aged 35 to 75 With Asymptomatic High Uric Acid Levels

What this Trial Is About

Researchers are evaluating an investigational drug called NNC4004-0002 to see if it can lower serum uric acid levels safely in adults with asymptomatic hyperuricemia. This is a Phase 1, double-blinded, placebo-controlled study where the safety and tolerability of a single dose of NNC4004-0002 will be tested for the first time in humans. The study aims to understand how the body handles this new medicine and its effects over time. Participants will receive either a single ascending dose of NNC4004-0002 or a matching placebo, both given as injections under the skin. The study includes up to six groups, each receiving different doses to assess safety and dose effects. Depending on the dose, participants may receive more than one injection. The study will last about 19 months in total, with each participant involved for approximately 7 months. During the study, participants will visit the clinic about 14 times, including a 4-night stay at the clinic. Researchers will monitor for any adverse events, measure the drug levels in the blood up to 72 hours after dosing, assess kidney clearance, and track changes in serum uric acid from baseline until about 28 weeks after dosing. Safety tests, physical exams, and lab tests will be conducted to ensure participant well-being throughout the study period.

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