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

OPKO Health

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteers

Treatments

Drug: Somatrogon

Study type

Interventional

Funder types

Industry

Identifiers

NCT03810664

CP-4-011

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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