hrp0086rfc8.4 | Growth: Clinical | ESPE2016
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...