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

This study has been completed.
Sponsor:
Information provided by:
Ascendis Pharma A/S
ClinicalTrials.gov Identifier:
NCT01010425
First received: November 6, 2009
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: ACP-001 (TransCon PEG hGH)
Drug: Placebo
Drug: Human Growth Hormone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)

Resource links provided by NLM:


Further study details as provided by Ascendis Pharma A/S:

Primary Outcome Measures:
  • Safety and Tolerability (adverse events, local reactions, immunogenicity) [ Time Frame: 0-42 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP [ Time Frame: 0-28 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACP-001, dose-level 1 Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 2 Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 3 Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 4 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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010425

Locations
Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Ascendis Pharma A/S
Investigators
Study Director: Ascendis Pharma Ascendis Pharma A/S
  More Information

No publications provided

Responsible Party: Study Director, Ascendis Pharma A/S
ClinicalTrials.gov Identifier: NCT01010425     History of Changes
Other Study ID Numbers: ACP-001 (Prot. 3695)
Study First Received: November 6, 2009
Last Updated: June 7, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014