Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01010425
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACP-001, dose-level 3 ACP-001 (TransCon PEG hGH) - ACP-001, dose-level 3 Placebo - ACP-001, dose-level 1 Human Growth Hormone - ACP-001, dose-level 2 ACP-001 (TransCon PEG hGH) - ACP-001, dose-level 2 Placebo - ACP-001, dose-level 2 Human Growth Hormone - ACP-001, dose-level 1 Placebo - ACP-001, dose-level 1 ACP-001 (TransCon PEG hGH) - ACP-001, dose-level 3 Human Growth Hormone - ACP-001, dose-level 4 ACP-001 (TransCon PEG hGH) - ACP-001, dose-level 4 Placebo - ACP-001, dose-level 4 Human Growth Hormone -
- Primary Outcome Measures
Name Time Method Safety and Tolerability (adverse events, local reactions, immunogenicity) 0-42 days Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP 0-28 days
- Secondary Outcome Measures
Name Time Method