Go to the page content
Healthy

A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults

Locations

Not recruiting

Start date

15/11/2022

Identifiers

Trial ID NN6582-4838,
NCT number NCT05624580,
Eudract number 2022-001813-38

Summary

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Trial Overview:

Condition

Healthy Volunteers

Treatment

DRUG: NNC0582-0001

DRUG: Placebo

Study type

INTERVENTIONAL

Trial duration

Nov 15 2022 - Sep 30 2025

Participants

56

Phase

I

Are you eligible?

Gender

Male and female

Age

18 to 55 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.