NCT03810664

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2019-01-18
• Primary completion: 2019-04-19
• Completion: 2019-04-19
• First posted: 2019-01-22
• Last updated: 2020-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study