A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People

A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Cardiometabolic Diseases
• Intervention / Treatment: Drug: NNC6022-0001; Drug: Placebo (NNC6022-0001)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Recruiting
    • ICON - location Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC6022-0001; Participants will be randomised to NNC6022-0001.	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 Comparator: Placebo (NNC6022-0001); Participants will be randomised to placebo.	Drug: Placebo (NNC6022-0001); Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to six cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAE)	Number of events	From time of dosing (Day 1) to end of study (Day 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
AUC0-∞, 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)
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)
IL-1β, 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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (Dept. 2834)., Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): October 17, 2024
• Study Completion (Estimated): October 17, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NN6022-7683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes