OR03-6 Intranasal administration of Human Growth Hormone (CP024) and induction of IGF-1 in healthy volunteers

Abstract

Results: All dose-levels of ACP-001 were safe and well tolerated. Most frequent AEs were headache and fatigue. Two SAEs occurred in one patient, judged as not drug-related. A total of nine patients experienced injection site reactions, the most frequent being mild erythema and reported across all treatment groups. No lipoatrophy at the injection site was observed. No treatment emergent antibodies occurred. Data showed pharmacokinetic and pharmacodynamic dose-response of the different dose levels of ACP-001. IGF-I levelsincreased in a dose-dependent manner and demonstrated a similar response for ACP-001 0.04mg/kg/week compared to the corresponding dose of daily hGH (0.04mg/kg/week). Conclusion: ACP-001 was safe and well tolerated in this Phase 2 study in adult patients with GrowthHormone Deficiency. Pharmacokinetic results support a once-weekly dosing. IGF-I increased in a dose-dependent manner and comparable to daily hGH, indicating that ACP-001 is at least as potent as the corresponding dose of daily hGH.