First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

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 assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

Official Title
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First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Conditions
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Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Healthy

Intervention / Treatment
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* Drug: somapacitan
* Drug: placebo (somapacitan)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking male subjects BMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl. Body weight 50 to 100 kg, both incl. Exclusion Criteria: Strenuous exercise within 4 days prior to dosing Receipt of any investigational medicinal product within 3 months prior to randomisation

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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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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose (SD)<br>Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation | Drug: somapacitan<br>* Administered s.c. (subcutaneously, under the skin)<br>* Other names: NNC0195-0092;Drug: placebo (somapacitan)<br>* Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)<br>|
| Experimental: Multiple dose (MD)<br>Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation | Drug: somapacitan<br>* Administered s.c. (subcutaneously, under the skin)<br>* Other names: NNC0195-0092;Drug: placebo (somapacitan)<br>* Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (Single Dose) |  | From first administration of trial product and up until day 40 | 
| Incidence of adverse events (Multiple Dose) |  | From first administration of trial product and up until day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve |  | From 0 to 168 hours | 
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) |  | From 0-240 hours | 
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) |  | up to day 40 | 
| Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) |  | up to day 40 | 
| Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve |  | From 0-168 hours | 
| Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) |  | From 0-240 hours | 
| Maximum serum concentration (Cmax) for IGF-I |  | up to day 40 | 
| Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve |  | From 0-168 hours | 
| Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) |  | From 0-240 hours | 
| Maximum serum concentration (Cmax) for IGFBP-3 |  | up to day 40 | 
| Number of injection site reactions |  | From first administration of trial product and up until day 40 (SD part) | 
| Number of injection site reactions |  | From first administration of trial product and up until day 49 (MD part) |