A safe test of a new medicine for healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1 trial evaluates the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy volunteers. Participants are randomly assigned to receive either NNC0705-0002 or placebo and will be monitored over up to about seven weeks, including screening and follow-up visits. The study is conducted in healthy adults to characterize safety signals before broader testing in patients with inflammation-related cardiometabolic concerns. Key assessments include vital signs, lab tests, ECGs, and monitoring for adverse events. The trial is sponsored by Novo Nordisk A/S with an ICON Groningen site participating in the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• ICON - location Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.