drugset / Trial / NCT04722653

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

NCT04722653

Phase 1 Completed 42 enrolled Novo Nordisk A/S
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-02-02
Primary completion
2021-04-27
Completion
2021-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject zalfermin Protein / enzyme biologic 12 mg Subcutaneous
Subject zalfermin Protein / enzyme biologic 30 mg Subcutaneous
Subject zalfermin Protein / enzyme biologic 96 mg Subcutaneous