Clinical Trial: Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset
Brief Summary: Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
Detailed Summary: 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).
Sponsor: Ambrx, Inc.
Current Primary Outcome: Temporal profiling of circulating IGF-1 levels. [ Time Frame: 3 period ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Body composition measurements at start of study and end of study [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Ambrx, Inc.
Dates:
Date Received: October 22, 2008
Date Started: July 2008
Date Completion:
Last Updated: October 9, 2009
Last Verified: October 2009