NCT00778518

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ambrx, Inc. · Industry
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	ARX201	Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
DRUG	ARX201	Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
DRUG	ARX201	Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-10-23
• Last updated: 2009-10-12

Locations

1 site across 1 country: Hungary