NCT07029568

A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People

A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (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 (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).

Conditions

• Healthy Volunteers
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	NNC0705-0001	NNC0705-0001 will be administered orally.
DRUG	Placebo	Placebo matching NNC0705-0001 will be administered orally.

Timeline

• Start date: 2025-06-13
• Primary completion: 2025-11-04
• Completion: 2025-12-10
• First posted: 2025-06-19
• Last updated: 2026-03-11

Locations

1 site across 1 country: Netherlands