Objective: Hybrid Fc-fused rhGH (GX-H9) is a long-acting recombinant human growth hormone (GH) under clinical development for both adults and children with GH deficiency (GHD). We compared the safety, pharmacokinetics and pharmacodynamics of weekly and every other week (EOW) dosages of GX-H9 with those of daily GH administration in adult GHD (AGHD) patients. Design: This was a randomized, open-label, active-controlled and dose-escalation study conducted in 16 endocrinology centers in Europe and Korea. Methods: Forty-five AGHD patients with or without prior GH treatment were enrolled. Patients with prior GH treatments were required to have received the last GH administration at least 1 month prior to randomization. Subjects were sequentially assigned to treatment groups. Fifteen subjects were enrolled to each treatment group and randomly assigned to receive either GX-H9 or Genotropin (4:1 ratio). GX-H9 dosage regimens for Groups 1, 2 and 3 were 0.1 mg/kg weekly, 0.3 mg/kg EOW and 0.2 mg/kg EOW, respectively. All Genotropin-assigned subjects received 6 μg/kg Genotropin, regardless of treatment group. Main outcome analyses included measurements of serum insulin-like growth factor 1 (IGF-I), safety, pharmacokinetics, pharmacodynamics and immunogenicity. Results: Mean GX-H9 peak and total exposure increased with an increase in dose after a single-dose administration. The mean IGF-I response was sustained above baseline over the intended dose interval of 168 h for the weekly and 336 h for the EOW GX-H9 groups. Safety profiles and immunogenicity were not different across the treatment groups and with Genotropin. Conclusions: GX-H9 has the potential for up to twice-monthly administration.
Bibliographical noteFunding Information:
The trial was financially supported by Handok and Genexine Inc. This study was supported by Korea Drug Development Fund (http://www.kddf. org) funded by a consortium of three health-related Korean Ministries – the Ministry of Science, ICT, and Future Planning; the Ministry of Trade, Industry, and Energy and the Ministry of Health and Welfare (KDDF-201502-11: Global Phase 2 study (AGHD) of next generation human growth hormone drug (GX-H9) in EU/KR and Approval of PGHD trial in EU).
All Science Journal Classification (ASJC) codes
- Endocrinology, Diabetes and Metabolism