A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

Detailed Description
-----------------
The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.

Official Title
-----------------
A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

Conditions
-----------------
Healthy Male Volunteers

Intervention / Treatment
-----------------
* Drug: Somatrogon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers aged 18-55 (inclusive) years Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg Non-smoking (by declaration) for a period of at least six months prior to screening visit Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatrogon pre-filled PEN<br> | Drug: Somatrogon<br>* A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).<br>|
| Active Comparator: Somatrogon frozen liquid formulation<br> | Drug: Somatrogon<br>* A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt) |  | 30 days | 
| Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞) |  | 30 days | 
| Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of IGF-1 and IGFBP-3 levels |  | 30 days | 
| AUC∞ of IGF-1 and IGFBP-3 levels |  | 30 days | 
| Cmax of IGF-1 and IGFBP-3 levels |  | 30 days | 
| Time to maximum concentration (Tmax) |  | 30 days | 
| Apparent Terminal Rate Constant (λz) and t½ |  | 30 days |