NCT02946606

A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9

A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.

Detailed description

The subjects who are adequately eligible to attend this clinical trial via screening will be sequentially assigned starting with Group 1. Each group will be comprised of subjects who will receive both GX-H9 and Genotropin, and subjects will be randomly assigned to either GX-H9 and Genotropin in the ratio of 4:1. The treatment will proceed as the proposed group order (Group 1, Group 2, Group 3), and safety and insulin-like growth factor (IGF-1) will be reviewed six weeks after each treatment by the safety monitoring committees before proceeding to the next group.

Conditions

• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	GX-H9	Human growth hormone
DRUG	Genotropin	Human growth hormone

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-30
• Completion: 2016-12-30
• First posted: 2016-10-27
• Last updated: 2017-09-07

Locations

1 site across 1 country: South Korea