A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Study Overview
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Brief Summary
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This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499. Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach. The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.

Official Title
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Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

Conditions
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Non-alcoholic Steatohepatitis

Intervention / Treatment
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* Drug: NNC0194-0499
* Drug: Placebo (NNC0194-0499 )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, aged 20-55 years (both inclusive) at the time of signing informed consent For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive) Body weight greater than or equal to 60 kg Exclusion Criteria: Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Parallel Assignment
Interventional Model Description: The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NN0194-0499<br>Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort. | Drug: NNC0194-0499<br>* 1 single dose administered subcutaneously (s.c. - under the skin)<br>|
| Placebo Comparator: Placebo<br>Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. | Drug: Placebo (NNC0194-0499 )<br>* 1 single dose administered subcutaneously (s.c. - under the skin).<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) | Count of events | From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration | h·nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration | h·nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration | h·nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration | nmol/L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration | Hours | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| t½, SD: Terminal half-life of NNC0194-0499 | Hours | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| CL/FSD: Apparent total serum clearance of NNC0194-0499 | L/h | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| Vz/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase | L | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | 
| MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration | Hours | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |