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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: NNC0582-0001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose 1: NNC0582-0001 10 milligram (mg)<br>Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|
| Experimental: Single Dose 2: NNC0582-0001 30 mg<br>Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|
| Experimental: Single Dose 3: NNC0582-0001 90 mg<br>Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|
| Experimental: Single Dose 4: NNC0582-0001 250 mg<br>Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|
| Experimental: Single Dose 5: NNC0582-0001 600 mg<br>Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|
| Experimental: Single Dose 6: NNC0582-0001 1000 mg<br>Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously. | Drug: NNC0582-0001<br>* 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.<br>Drug: Placebo<br>* Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.<br>|

What is the study measuring?
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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 End of Study visit (Week 52) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞: 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 | 
| 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 | 
| 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 |