NCT01060722

MOD-4023 Study in Healthy Male Volunteers

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of a Long Acting Human Growth Hormone (hGH) Product (MOD-4023), in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to examine the safety, tolerability and pharmacokinetics of a long-lasting Human Growth Hormone (MOD-4023) in healthy volunteers after a single subcutaneous injection at escalating doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MOD-4023 (long lasting hGH)	Single subcutaneous dose of MOD-4023
DRUG	Placebo	Single subcutaneous dose of placebo material

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-02-02
• Last updated: 2019-09-30

Locations

1 site across 1 country: Israel