Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.

Official Title
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Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.

Conditions
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Growth Hormone Disorder, Healthy

Intervention / Treatment
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* Drug: NNC126-0083
* Drug: NNC126-0083
* Drug: NNC126-0083
* Drug: NNC126-0083
* Drug: placebo
* Drug: placebo
* Drug: placebo
* Drug: placebo
* Drug: NNC126-0083
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects with Japanese passport and Japanese born parents Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive Subjects must be in good health according to age 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 History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: A<br> | Drug: NNC126-0083<br>* Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks<br>Drug: placebo<br>* Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>|
| Experimental: B<br> | Drug: NNC126-0083<br>* Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks<br>Drug: placebo<br>* Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>|
| Experimental: C<br> | Drug: NNC126-0083<br>* Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks<br>Drug: placebo<br>* Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>|
| Experimental: D<br> | Drug: NNC126-0083<br>* Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>Drug: placebo<br>* Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>|
| Experimental: E<br> | Drug: NNC126-0083<br>* Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks<br>Drug: placebo<br>* Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (adverse events, local tolerability, physical examination) |  | 0 to 10 days after third dosing, (day 15-25 after first dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, maximum concentration of IGF-I |  | 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose) |