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

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336005
• Other study ID #: NN6022-7683
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Cardiometabolic Diseases
• Healthy Volunteers

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)