Dose Study in Growth Hormone Deficient Adults 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 NNC126-0083 in growth hormone deficient adults

Official Title
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Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)

Conditions
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Growth Hormone Disorder, Adult Growth Hormone Deficiency

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion GH replacement therapy for more than 3 months Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive Exclusion Criteria: Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods Malignant disease Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes Heart insufficiency, NYHA class greater than 2 Subjects with diabetes with an HbA1C above 8.0% Diabetic receiving insulin treatment Stable pituitary replacement therapy for less than 3 months Impaired liver function Impaired kidney function

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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>* Other names: pegylated long-acting human growth hormone;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>* Other names: pegylated long-acting human growth hormone;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>* Other names: pegylated long-acting human growth hormone;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 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks<br>* Other names: pegylated long-acting human growth hormone;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 |  | after trial product administration |