Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
NCT ID: NCT01010425
Last Updated: 2010-06-08
Study Results
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Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2009-11-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ACP-001, dose-level 1
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Placebo
Placebo, s.c., single-dose
Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
ACP-001, dose-level 2
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Placebo
Placebo, s.c., single-dose
Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
ACP-001, dose-level 3
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Placebo
Placebo, s.c., single-dose
Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
ACP-001, dose-level 4
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Placebo
Placebo, s.c., single-dose
Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Interventions
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ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Placebo
Placebo, s.c., single-dose
Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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 cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
* Others
20 Years
45 Years
MALE
Yes
Sponsors
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Ascendis Pharma A/S
INDUSTRY
Responsible Party
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Ascendis Pharma A/S
Principal Investigators
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Ascendis Pharma
Role: STUDY_DIRECTOR
Ascendis Pharma A/S
Locations
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Toronto, Ontario, Canada
Countries
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References
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Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.
Other Identifiers
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ACP-001 (Prot. 3695)
Identifier Type: -
Identifier Source: org_study_id
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