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RECRUITING Phase 1 ClinicalTrials.gov

A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT07797855

Registry updated: 2026-09-30
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Description

This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.

Interventions

  • NNC0705-0002 (Drug)
    Participants will receive oral capsule of NNC0705-0002.
  • Placebo (Drug)
    Participants will receive oral capsule of placebo matched to NNC0705-0002.

Eligibility criteria

Inclusion Criteria: * Men or women of non-childbearing potential. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 18.5 to 29.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening. * Body weight: greater than or equal to (≥) 50.0 kg at screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values. * Alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) * Aspartate aminotransferase (AST) \>ULN * Total bilirubin (TBL) \>ULN * Creatinine \>ULN * International normalised ratio (INR) \>ULN * High-sensitivity C-reactive protein (hsCRP) greater than (\>)5 milligram per liter (mg/L) (males) and \>8 mg/L (females) * Use of prescription medicinal products or vaccines within 14 days before dosing and/or non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter acetaminophen/paracetamol and/or nonsteroidal anti-inflammatory drugs at their labelled doses for mild pain; vitamins at their labelled doses.

Conditions

Healthy Volunteers Cardiometabolic Diseases

Locations

  • ICON - location Groningen — Groningen, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record