NCT04722653

A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499. Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach. The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	NNC0194-0499	1 single dose administered subcutaneously (s.c. - under the skin)
DRUG	Placebo (NNC0194-0499 )	1 single dose administered subcutaneously (s.c. - under the skin).

Timeline

• Start date: 2021-02-02
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2021-01-25
• Last updated: 2022-04-05

Locations

1 site across 1 country: Japan