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Recruiting
NCT05599945
First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: Novo Nordisk A/S
Location: United Kingdom
Summary
This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with four sequential single ascending dose (SAD) levels in healthy adult participants.
This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581 0001 and explores the pharmacodynamics in healthy participants.
Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0581 0001 or placebo by injections under the skin.
Participants will be followed up for 52 weeks post dose.
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 percentAspartate aminotransferase (AST) greater than UNL plus 10 percentBilirubin greater than UNL plus 10 percentEstimated 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.
Source: ClinicalTrials.gov (NCT05599945). StuddyBuddy aggregates publicly available trial information.