A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People

Launched by NOVO NORDISK A/S · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called NNC0705-0001 to see if it is safe for healthy people. The medicine is being studied because it might help reduce chronic inflammation in the body, which is linked to higher risks of heart and metabolic diseases. The study will look at how the medicine works in the body and how the body processes it. Participants will either receive the new medicine or a placebo, which is a harmless pill without any active ingredients. The study has three parts, including taking single doses, multiple doses, and seeing how food affects the medicine. The whole process will take about 1 to 1.5 months depending on the part.

People who may join the study need to be healthy men or women who cannot become pregnant, between 18 and 55 years old, with a body weight of at least 50 kilograms (about 110 pounds) and a body mass index (BMI) within a normal range (18.5 to 29.9). Before joining, participants will have a health check to make sure they meet these requirements. During the study, they will be closely monitored to make sure the medicine is safe and to learn how it affects the body. It’s important to note that anyone with allergies to similar medicines or certain health conditions would not be eligible. Also, participants should avoid taking other medicines or vaccines shortly before joining. This study is not yet recruiting but aims to provide important information about the safety of this new potential treatment.

Gender

ALL

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 meter square (kg/m\^2) (both inclusive) at screening.
• • Body weight: greater than or equal to (≥) 50 kilogram (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 (BIL) \> ULN; Creatinine \> ULN; International normalized ratio (INR) \> ULN; High-Sensitivity C-Reactive Protein (hsCRP) \> 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 paracetamol and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.