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

Healthy Volunteers Clinical Trial

Official title:

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624580
• Other study ID #: NN6582-4838
• Secondary ID: U1111-1274-43162
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: June 2, 2025

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 2, 2025
• Est. primary completion date: June 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.

• Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

• Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.

• Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):

• Alanine aminotransferase (ALT)

• Aspartate aminotransferase (AST)

• Bilirubin

• Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• NNC0582-0001
Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.
• Placebo
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From dosing (Day 1) until End of Study visit (Week 52)
Secondary	AUC0-8: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.	Measured in hours * nanogram per mililiter (h*ng/mL).	From dosing (Day 1) to 168 hours after dosing
Secondary	Cmax: The maximum concentration of NNC0582-0001 in plasma	Measured in nanogram per mililiter (ng/mL).	From dosing (Day 1) to 168 hours after dosing
Secondary	tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001	Measured in days.	From dosing (Day 1) to 168 hours after dosing