New medicine NNC0642-1895 safety test in 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 is a Phase 1 interventional trial enrolling healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of a single rising dose of NNC0642-1895 versus placebo. Participants are randomly assigned to receive either the study drug or a placebo and are monitored over about 14 weeks. The study includes careful screening, dosing, and follow-up to capture safety labs, vital signs, and possible adverse events. The trial is conducted at ICON in Salt Lake City, with Novo Nordisk A/S as the lead sponsor. Enrollment targets adults aged 18 to 55 who are generally healthy per predefined criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female (sex assigned at birth, inclusive of all gender identities).
* 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 meter (kg/m\^2) (both inclusive) 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 laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

  * Alanine aminotransferase (ALT) greater than (\>) Upper limit of normal (ULN) +10 percent (%)
  * Aspartate aminotransferase (AST) \> ULN +20%
  * Bilirubin \> ULN +20%
  * Creatinine \> ULN +10%
  * Absolute neutrophil count \> ULN
  * Absolute neutrophil count less than (\<) Lower limit of normal (LLN)
  * Platelet count \> ULN
  * Platelet count \< LLN
* Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic
* Heart rate outside the range of 50-90 beats/min at screening
* Use of prescription (except contraceptives) or non-prescription medicinal products within 14 days before screening. Occasional use of over-the-counter acetaminophen or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) at their labelled doses is permitted.

Where it's running

• ICON-Salt Lake City
  Salt Lake City, Utah, United States 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.