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Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

Growth Hormone Deficiency Clinical Trial

Official title:
A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers

Clinical Trial Summary

The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.

Following a 4-week screening period, eligible male subjects will be stratified by ethnic group and will be randomized to one of six groups. On dosing day, designated as Day 1, each subject will receive single SC injection of study medication according to group allocation and will be followed up for a month for safety monitoring.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02418767
Study type Interventional
Source OPKO Health, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 2015
Completion date June 2015
View Details
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