NCT01225666

MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)

A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 23 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.

Detailed description

The study is a phase II, randomized, open-label, parallel, 4 active treatment arms study to evaluate the safety, tolerability and PK/PD profile of MOD-4023 in pre-treated, normalized, GHD adults. The study is conducted in 2 stages. Stage I is a 4-week treatment period with 4 different dose levels/dosing regimens. Stage II is a 16-week treatment-extension period in which all the patients will start with the same dose (derived from stage I) and will be dose titrated to maintain IGF-1 levels within the normal range.

Conditions

• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	MOD-4023	liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly
DRUG	MOD-4023	liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly
DRUG	MOD-4023	liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly
DRUG	MOD-4023	liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-07-01
• Completion: 2012-04-01
• First posted: 2010-10-21
• Last updated: 2019-10-08

Locations

15 sites across 6 countries: Czechia, Hungary, Israel, Serbia, Slovakia, Slovenia