NCT06336005

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Cardiometabolic Diseases

Interventions

Type	Name	Description
DRUG	NNC6022-0001	Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.
DRUG	Placebo (NNC6022-0001)	Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-02-10
• Completion: 2025-02-17
• First posted: 2024-03-28
• Last updated: 2025-04-16

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study