Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males

NN9500-4796

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.

2023-02-16

2023-06-13

2023-06-13

Completed

Early phase I

24

Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m\^2) (both inclusive). * Body weight greater than or equal to 60 kg. * Considered eligible 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 or related products. * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-10-16