Trial | NCT01010425  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin lonapegsomatropin ...

  • Study Participants

    44
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
Study Started
Nov 30
2009
Primary Completion
Feb 28
2010
Study Completion
May 31
2010
Last Update
Jun 08
2010
Estimate

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

ACP-001, dose-level 1 Experimental

ACP-001, dose-level 2 Experimental

ACP-001, dose-level 3 Experimental

ACP-001, dose-level 4 Experimental

Criteria 

Inclusion Criteria:

Healthy male subjects
20 to 45 years old
Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
Others

Exclusion Criteria:

Known history of hypersensitivity to human growth hormone (hGH)
Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
Others
No Results Posted