A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age35-75
SponsorNovo Nordisk A/S
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF).
Considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening.
Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (the first at the screening visit [V1], and the second taken at V2 [day -1]; samples at least 7 days apart).
Disqualifiers
Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method.
Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
Present or prior history of gout, or present or prior use of serum Uric acid (sUA) lowering medication.
Serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
Trial design
Design model
Sequential
Treatments tested in this trial
NNC4004-0002
DrugNNC4004-0002 will be given as a single ascending dose via subcutaneous route.
Placebo
DrugPlacebo matched to NNC4004-0002 will be given via subcutaneous route.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: NNC4004-0002Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Treatment-emergent adverse event (TEAEs)
Count
Time frame
From dosing (day 1) until end of study (approximately 28 weeks)Secondary outcomes
1
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)
Time frame
From dosing (day 1) to 72 hours postdose2
Cmax: The maximum concentration of NNC4004-0002 in plasma
microgram/mililiter
Time frame
From dosing (day 1) to 72 hours postdose3
tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002
Hours
Time frame
From dosing (day 1) to 72 hours postdose4
Renal clearance
Liter/hour (L/h)
Time frame
From time of dose to 72 hours postdoseSponsors and contacts
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Source ClinicalTrials.gov