First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with four sequential single ascending dose (SAD) levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581 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 NNC0581 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: NNC0581-0001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Recruiting
      • Parexel CPRU, Level 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 18.5 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.
• Any laboratory safety parameters at screening outside the below laboratory ranges, 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) greater than upper normal limit (UNL) plus 10 percent
• Aspartate aminotransferase (AST) greater than UNL plus 10 percent
• Bilirubin greater than UNL plus 10 percent
• Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2)
• Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose 1: NNC0581-0001 10 milligram (mg); Participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.	Drug: NNC0581-0001; Participants will receive up to four single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: Single Dose 2: NNC0581-0001 30 mg; Participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.	Drug: NNC0581-0001; Participants will receive up to four single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: Single Dose 3: NNC0581-0001 90 mg; Participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.	Drug: NNC0581-0001; Participants will receive up to four single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Experimental: Single Dose 4: NNC0581-0001 250 mg; Participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.	Drug: NNC0581-0001; Participants will receive up to four single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.; Drug: Placebo; Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From dosing (Day 1) until completion of the End of Study Visit at week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose	Measured in nanomole hour per liter (nmol h/L).	From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose	Measured in nanomole per liter (nmol/L).	From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose	Measured in days.	From dosing (Day 1) to 168 hours after dosing

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): January 22, 2025
• Study Completion (Estimated): August 28, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NN6581-4860; U1111-1274-4577 (Other Identifier: World Health Organization (WHO)); 2022-001359-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No