NCT01247675

A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency

A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Ascendis Pharma A/S · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.

Conditions

• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	ACP-001 (TransCon hGH)	s.c., weekly injection
DRUG	ACP-001 (TransCon hGH)	s.c., weekly injection
DRUG	ACP-001 (TransCon hGH)	s.c., weekly injection
DRUG	Omnitrope	s.c., daily injection

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-11-24
• Last updated: 2017-03-09
• Results posted: 2017-03-09

Locations

4 sites across 4 countries: Denmark, Germany, Italy, Sweden