hrp0086rfc8.4 | Growth: Clinical | ESPE2016

A Hybrid Fc-fused Human Growth Hormone, GX-H9, Shows a Potential for Weekly and Semi-monthly Administration in Clinical Studies

Lee EunJig , Schopohl Jochen , Mykola Aryaev , Kim Tae Kyung , Ahn Young-Joo , Woo Jung-Won , Jang Woo Ick , Sung Young-Chul , Keyoung H. Michael

Background, Objective and hypotheses: GX-H9 is a hybrid Fc-based long-acting recombinant human growth hormone (hGH). The safety, tolerability, and PK/PD of single ascending dose in healthy volunteers were assessed to determine GX-H9 doses capable of normalizing IGF-1 level. The PK/PD, safety, efficacy and tolerability of multiple sequential doses of GX-H9 in adult growth hormone deficiency (AGHD) were compared to that of a daily recombinant hGH in AGHD. A Phase 2 study in pedi...