Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers

Official Title
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A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects

Conditions
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Growth Hormone Disorder, Healthy

Intervention / Treatment
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* Drug: NNC126-0083
* Drug: Norditropin® SimpleXx®
* Drug: placebo
* Drug: NNC126-0083
* Drug: Norditropin® SimpleXx®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking male subjects Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive Body weight max. 100 kg Exclusion Criteria: A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies Positive result of test for HIV (Human Immunodeficiency Virus) antibodies Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits) Habitual smoking, i.e daily smoking or more than 7 cigarettes/week Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial Surgery or trauma with significant blood loss within the last 2 months prior to dosing

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083<br> | Drug: NNC126-0083<br>* One of five dose levels administered subcutaneously (under the skin)<br>Drug: Norditropin® SimpleXx®<br>* One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)<br>|
| Experimental: Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083<br> | Drug: NNC126-0083<br>* One of five dose levels administered subcutaneously (under the skin)<br>Drug: Norditropin® SimpleXx®<br>* One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)<br>|
| Placebo Comparator: Norditropin® SimpleXx® 0.02 mg/kg + placebo<br> | Drug: placebo<br>* Placebo comparator<br>Drug: Norditropin® SimpleXx®<br>* One of two dose levels, followed by placebo, administered subcutaneously (under the skin)<br>|
| Placebo Comparator: Norditropin® SimpleXx® 0.04 mg/kg + placebo<br> | Drug: placebo<br>* Placebo comparator<br>Drug: Norditropin® SimpleXx®<br>* One of two dose levels, followed by placebo, administered subcutaneously (under the skin)<br>|
| Experimental: NNC126-0083<br> | Drug: NNC126-0083<br>* One of three dose levels administered subcutaneously (under the skin)<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | after administration of a single dose of NNC126-0083 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083 |  | 0-168 hours after trial drug administration | 
| Number of injection site reactions |  | after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx® | 
| IGF-I (Insulin-like Growth Factor I) levels |  | after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx® |