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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010425
First Posted: November 10, 2009
Last Update Posted: June 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ascendis Pharma A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)

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 ]
  • Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP [ Time Frame: 0-28 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Study Director, Ascendis Pharma A/S
ClinicalTrials.gov Identifier: NCT01010425     History of Changes
Other Study ID Numbers: ACP-001 (Prot. 3695)
First Submitted: November 6, 2009
First Posted: November 10, 2009
Last Update Posted: June 8, 2010
Last Verified: June 2010

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