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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
History of Changes
  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:

Drug Information available for: Somatropin
U.S. FDA Resources

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
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 May 16, 2013