To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)). To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Pharmacokinetic-area under plasma concentration versus time curve
Time frame: up to 52 weeks
Pharmacokinetic-maximum serum concentration
Time frame: up to 52weeks
Pharmacokinetic-time to reach the maximum plasma concentration
Time frame: up to 52 weeks
Pharmacokinetic-terminal disposition phase half-life
Time frame: up to 52 weeks
Pharmacokinetic-terminal elimination rate constant
Time frame: up to 52 weeks
Pharmacokinetic-apparent clearance after extravascular administration
Time frame: up to 52 weeks
Pharmacokinetic-apparent volume of distribution
Time frame: up to 52 weeks
Pharmacodynamics-the properties of Insulin-like growth facto1 and Insulin-like growth factor binding receptor 3.
Time frame: up to 57 weeks
Height velocity (HV, cm/year)
Time frame: At 52 weeks of treatment
Change of height velocity compared to baseline (ΔHV, cm/year)
Time frame: At 52 weeks of treatment
Height standard deviation according to chronological age (Ht SDS CA)
Time frame: At 52 weeks of treatment
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rhGH, 470μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, Hainan, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
...and 9 more locations
Change in bone age
Time frame: At 52 weeks of treatment
Adverse events (including injection site reactions), changes from baseline in vital signs and laboratory tests
Time frame: up to 57 weeks