NCT01010425

Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ascendis Pharma A/S · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACP-001 (TransCon PEG hGH)	ACP-001, dose-level 1, s.c., single-dose
DRUG	ACP-001 (TransCon PEG hGH)	ACP-001, dose-level 2, s.c., single-dose
DRUG	ACP-001 (TransCon PEG hGH)	ACP-001, dose-level 3, s.c., single-dose
DRUG	ACP-001 (TransCon PEG hGH)	ACP-001, dose-level 4, s.c., single-dose
DRUG	Placebo	Placebo, s.c., single-dose
DRUG	Human Growth Hormone	Human Growth Hormone, s.c., daily for 7 days

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2009-11-10
• Last updated: 2010-06-08

Locations

1 site across 1 country: Canada