drugset
drugset / Trial / NCT01247675

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

NCT01247675 ↗

Phase 2 Completed 37 enrolled Ascendis Pharma A/S
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-11
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ACP-001 Protein / enzyme biologic 0.02 mg/kg Subcutaneous
Subject ACP-001 Protein / enzyme biologic 0.04 mg/kg Subcutaneous
Subject ACP-001 Protein / enzyme biologic 0.08 mg/kg Subcutaneous
Comparator Somatropin Protein / enzyme biologic 0.04 mg/kg Subcutaneous

Indications

pituitary deficiency