Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

Inclusion Criteria:

• 18-30 years old
• GHD of childhood onset
• completed growth
• IGF-1 <=2SDS
• rhGH treatment naive
• hGH levels below cut-off

Exclusion Criteria:

• History of malignancy or intracranial tumors
• ECG abnormality
• ICH
• hepatic dysfunction
• renal impairment
• major medical conditions
• inadequate T4
• positive for HBV, HCV, or HIV
• alcohol or drug abuse