NNC4004-0002
DrugNNC4004-0002 will be given as a single ascending dose via subcutaneous route.
NCT Number: NCT06859073
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.
Interested in participating?
Request Info35 year–75 year
All sexes
Interventional
Phase 1
PAREXEL Glendale/LA EPCU, Glendale, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NNC4004-0002 will be given as a single ascending dose via subcutaneous route.
Placebo matched to NNC4004-0002 will be given via subcutaneous route.
Time frame: From dosing (day 1) until end of study (approximately 28 weeks)
Count
Time frame: From dosing (day 1) to 72 hours postdose
microgram•hour/mililiter (μg•h/mL)
Time frame: From dosing (day 1) to 72 hours postdose
microgram/mililiter
Time frame: From dosing (day 1) to 72 hours postdose
Hours
Time frame: From time of dose to 72 hours postdose
Liter/hour (L/h)
Time frame: From baseline through the end of the study (approximately 28 weeks)
miligram/deciliter
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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