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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Opko Biologics

Current Primary Outcome:

• Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions [ Time Frame: 30 days ]
  To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.
• Pharmacokinetics (PK) profile of MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose [ Time Frame: 7 days ]
  MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax)

Original Primary Outcome: Same as current

Current Secondary Outcome: Pharmacodynamic (PD) profile (IGF-1 and IGFBP-3 levels) to MOD-4023 in healthy Caucasian and Japanese subjects after single SC dose [ Time Frame: 14 days ]

Original Secondary Outcome: Same as current

Information By: Opko Biologics

Dates:
Date Received: January 8, 2015
Date Started: January 2015
Date Completion:
Last Updated: October 28, 2015
Last Verified: April 2015