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

Adult Growth Hormone Deficiency Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02946606
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 2
Start date January 2015
Completion date December 30, 2016
View Details
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