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

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ClinicalTrials.gov Identifier: NCT01010425
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
Ascendis Pharma A/S

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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)
Study Start Date : November 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety and Tolerability (adverse events, local reactions, immunogenicity) [ Time Frame: 0-42 days ]
  2. Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP [ Time Frame: 0-28 days ]


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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Ascendis Pharma A/S
ClinicalTrials.gov Identifier: NCT01010425     History of Changes
Other Study ID Numbers: ACP-001 (Prot. 3695)
First Posted: November 10, 2009    Key Record Dates
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