First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
Healthy Volunteers
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) from 18.5 to 30.0 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: Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Any laboratory safety parameters at screening outside the below laboratory ranges, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters): Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent Aspartate aminotransferase (AST) greater than UNL plus 10 percent Bilirubin greater than UNL plus 10 percent Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2) Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Single Dose 1: NNC0581-0001 10 milligram (mg)
Single Dose 2: NNC0581-0001 30 mg
Single Dose 3: NNC0581-0001 90 mg
Single Dose 4: NNC0581-0001 250 mg
Participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.