A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC4004-0002, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, Hyperuricemia. Basic parameters: 35 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Double-blinded, Placebo-controlled Study of Single Ascending Doses of NNC4004-0002 in Adults With Asymptomatic Hyperuricemia
Overview
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.
Interventions
- Drug NNC4004-0002
NNC4004-0002 will be given as a single ascending dose via subcutaneous route. - Drug Placebo
Placebo matched to NNC4004-0002 will be given via subcutaneous route.
Primary outcome measures
- Number of Treatment-emergent adverse event (TEAEs) [Time frame: From dosing (day 1) until end of study (approximately 28 weeks)]
Secondary outcome measures (5)
- AUC(0-72): The area under the NNC4004-0002 plasma concentration-time curve from time zero to the 72 hours after a single dose [Time frame: From dosing (day 1) to 72 hours postdose]
- Cmax: The maximum concentration of NNC4004-0002 in plasma [Time frame: From dosing (day 1) to 72 hours postdose]
- tmax: The time from dose administration to the maximum plasma concentration of NNC4004-0002 [Time frame: From dosing (day 1) to 72 hours postdose]
- Renal clearance [Time frame: From time of dose to 72 hours postdose]
- Changes in serum Uric Acid (sUA) over time [Time frame: From baseline through the end of the study (approximately 28 weeks)]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
- History or current diagnosis of chronic history kidney disease.
- Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values greater than (>) 2 multiply by (×) upper limit normal (ULN) or total bilirubin >1.5× ULN.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- PAREXEL Glendale/LA EPCU — Glendale
- PAREXEL Intl - EPCU-Baltimore — Baltimore
Identifiers
NCT: NCT06859073 · NN4004-8071 · U1111-1317-9961