Clinical trial NCT06336005: A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People
Official title: A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Cardiometabolic Diseases
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAE)
timeFrame: From time of dosing (Day 1) to end of study (Day 14)
Secondary outcomes:
measure: 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
timeFrame: From pre-dose (Day 1) to end of exposure (Day 7)
measure: AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (Day 1) to end of exposure (Day 7)
measure: Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose
timeFrame: From pre-dose (Day 1) to end of exposure (Day 7)
measure: IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline
timeFrame: From pre-dose (Day 1) to estimated tmax (Day 1)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON - location Groningen
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept. 2834).
role: STUDY_DIRECTOR
References: