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

Verified by: Ascendis Pharma A/S, June 2010
First Received: November 6, 2009 | Last Updated: June 7, 2010 | Phase: Phase 1 | Start Date: November 2009
Overall Status: Completed | Estimated Enrollment: 44
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Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH)...

Brief Summary

Official Title: “Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: ACP-001, dose-level 1
  • Experimental: ACP-001, dose-level 2
  • Experimental: ACP-001, dose-level 3
  • Experimental: ACP-001, dose-level 4

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety and Tolerability (adverse events, local reactions, immunogenicity)
    • Time Frame: 0-42 days
      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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Ascendis Pharma A/S Industry

Overall Clinical Trial Officials and Contacts

Ascendis Pharma Study Director Ascendis Pharma A/S  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010425

Study ID Number: ACP-001 (Prot. 3695)

ClinicalTrials.gov Identifier: NCT01010425

Health Authority: Canada: Health Canada

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01010425