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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

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

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

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

Lead Sponsor: Ascendis Pharma A/S

Overall Clinical Trial Officials and Contacts

Ascendis Pharma Study Director Ascendis Pharma A/S  

Information obtained from ClinicalTrials.gov on February 04, 2010

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