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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06336005
Other study ID # NN6022-7683
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 28, 2024
Est. completion date October 17, 2024

Study information

Verified date April 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine. Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors. The study will last for about 10 months in total.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date October 17, 2024
Est. primary completion date October 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Men or women of non-childbearing potential. 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening. 4. Body Weight: Greater than or equal to 50 kg at screening. 5. 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: 1. Known or suspected hypersensitivity to study intervention(s) or similar products. 2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 3. Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:. - Alanine Aminotransferase (ALT) above upper normal limit (UNL) - Aspartate aminotransferase (AST) above UNL - Total Bilirubin (BL) above UNL - Creatinine above UNL - International normalized ratio (INR) above UNL - Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L) - C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females) 4. 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 paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NNC6022-0001
Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to six cohorts.
Placebo (NNC6022-0001)
Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to six cohorts

Locations

Country Name City State
Netherlands ICON - location Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment emergent adverse events (TEAE) Number of events From time of dosing (Day 1) to end of study (Day 14)
Secondary AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose Hours*micrometer (hr×µM) From pre-dose (Day 1) to end of exposure (Day 7)
Secondary AUC0-8, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose Hours*micrometer (hr×µM) From pre-dose (Day 1) to end of exposure (Day 7)
Secondary Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose Micrometer (µM) From pre-dose (Day 1) to end of exposure (Day 7)
Secondary IL-1ß, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline Percentage (%) From pre-dose (Day 1) to estimated tmax (Day 1)
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