A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovo Nordisk A/S
About this trial
This study is testing a new medicine, in healthy adults to assess its safety and understand how it behaves in the body. The purpose of this study is to evaluate the safety, tolerability, and how the body responds to a single dose of NNC0642-1895 in healthy adults. Participant will either get study medicine (NNC0642-1895) or placebo (a treatment that has no active medicine in it). Which treatment a participant receives is decided by chance. NNC0642-1895 is a new medicine that is being tested in humans for the first time and is not currently available for doctors to prescribe. The study will last for about 94 days (approximately 14 weeks).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female (sex assigned at birth, inclusive of all gender identities).
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 square meter (kg/m²) (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.
Disqualifiers
Known or suspected hypersensitivity to study intervention(s) or related products.
Alanine aminotransferase (ALT) greater than (>) Upper limit of normal (ULN) +10 percent (%)
Aspartate aminotransferase (AST) > ULN +20%
Bilirubin > ULN +20%
Trial design
Design model
Parallel
Treatments tested in this trial
NNC0642-1895
DrugNNC0642-1895 will be administered intravenously.
Placebo
DrugPlacebo will be administered intravenously.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: NNC0642-1895Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of treatment emergent adverse events (TEAE)
Measured as number of events.
Time frame
From pre-dose (Day 1) to Day 66Secondary outcomes
1
AUC0-∞; the area under the NNC0642-1895 serum concentration-time curve from time 0 to infinity after a single dose
Measured as nanomoles per liter hour (nmol/L\*h).
Time frame
From pre-dose (Day 1) to Day 662
Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose
Measured as nanomoles per liter (nmol/L).
Time frame
From pre-dose (Day 1) to Day 66Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: