NCT05521256

A Research Study of a New Medicine NNC0113-6856 in Healthy Males

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Oral Single Doses of NNC0113-6856 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In this study NN0113-6856 will be given to humans for the first time. We will be looking into how safe different single doses of the new investigational product NNC0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. The study will look at the effects of different single doses of NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous \[IV\]-cohort). Participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort). The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).

Conditions

• Healthy Volunteers
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	NNC0113-6856	Participants will receive NN0113-6856 orally or intravenously.
DRUG	Placebo	Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2022-08-30
• Last updated: 2025-12-31

Locations

3 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study