NCT06284798

A Research Study of a New Medicine (NNC0650-0013) in Healthy Men

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	NNC0650-0013 A	NNC0650-0013 will be administered subcutaneously or intravenously.
DRUG	Placebo	Subcutaneous administration.

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2024-02-29
• Last updated: 2025-12-05

Locations

1 site across 1 country: Germany