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

Phase 1 Completed 44 enrolled Ascendis Pharma A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2009-11
Primary completion: 2010-02
Completion: 2010-05

Publications

Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACP-001	Protein / enzyme biologic	0.04 mg/kg	Subcutaneous
Subject	ACP-001	Protein / enzyme biologic	0.08 mg/kg	Subcutaneous
Subject	ACP-001	Protein / enzyme biologic	0.16 mg/kg	Subcutaneous
Subject	ACP-001	Protein / enzyme biologic	0.24 mg/kg	Subcutaneous
Subject	Somatropin	Protein / enzyme biologic	0.08 mg/kg	Subcutaneous
Subject	Somatropin	Protein / enzyme biologic	0.16 mg/kg	Subcutaneous

Indications

No indication recorded.