This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
s.c., weekly injection
s.c., weekly injection
s.c., weekly injection
Aarhus University Hospital
Aarhus, Denmark
Charité University Hospital Berlin
Berlin, Germany
University Hospital Genova
Genova, Italy
Karolinska University Hospital
Stockholm, Sweden
Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.
Time frame: Start of study treatment through Week 4
Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation
Number of subjects with treatment emergent anti-hGH binding antibodies
Time frame: Start of study treatment through Day 42
Cmax of hGH
As part of the following endpoint: Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group. Cmax (maximum value of concentration) values at Week 4
Time frame: Days 22 to 29
Emax of IGF-I
As part of the following endpoint: Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group. Emax (maximum observed response) values at Week 4
Time frame: Days 22 to 29
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s.c., daily injection