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

Primary Purpose

Healthy Volunteers

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NNC0581-0001
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Single Dose 1: NNC0581-0001 10 milligram (mg)

Single Dose 2: NNC0581-0001 30 mg

Single Dose 3: NNC0581-0001 90 mg

Single Dose 4: NNC0581-0001 250 mg

Arm Description

Participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.

Participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.

Participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.

Participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)
Measured as number of events.

Secondary Outcome Measures

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).
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose
Measured in nanomole per liter (nmol/L).
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose
Measured in days.

Full Information

First Posted
October 26, 2022
Last Updated
December 5, 2022
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05599945
Brief Title
First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
Official Title
A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
January 22, 2025 (Anticipated)
Study Completion Date
January 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Dose 1: NNC0581-0001 10 milligram (mg)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Arm Title
Single Dose 2: NNC0581-0001 30 mg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Arm Title
Single Dose 3: NNC0581-0001 90 mg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Arm Title
Single Dose 4: NNC0581-0001 250 mg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Intervention Type
Drug
Intervention Name(s)
NNC0581-0001
Intervention Description
Participants will receive up to four single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
Measured as number of events.
Time Frame
From dosing (Day 1) until completion of the End of Study Visit at week 52
Secondary Outcome Measure Information:
Title
AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose
Description
Measured in nanomole hour per liter (nmol h/L).
Time Frame
From dosing (Day 1) to 168 hours after dosing
Title
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose
Description
Measured in nanomole per liter (nmol/L).
Time Frame
From dosing (Day 1) to 168 hours after dosing
Title
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose
Description
Measured in days.
Time Frame
From dosing (Day 1) to 168 hours after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

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

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