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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2019-04-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Somatrogon pre-filled PEN

Group Type EXPERIMENTAL

Somatrogon

Intervention Type DRUG

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).

Somatrogon frozen liquid formulation

Group Type ACTIVE_COMPARATOR

Somatrogon

Intervention Type DRUG

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).

Interventions

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Somatrogon

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).

Intervention Type DRUG

Eligibility Criteria

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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