A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults
A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults
This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.
Inclusion Criteria:
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.
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.
clinicaltrials@novonordisk.com(+1) 866-867-7178