This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week
Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week
Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, China
Huashan Hospital, Fudan University
Shanghai, China
West China Hospital, Sichuan University
Sichuan, China
Adverse Event
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Serious Adverse Event
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
HR (bpm)
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
PR (ms)
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QRS (ms)
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QT (ms)
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QTc (ms)
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of participants with clinically significant changes in imaging examinations
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body weight
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body Mass Index
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body temperature
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
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Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week
Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week
Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee
The First Affiliated Hospital of Xiamen University
Xiamen, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China
pulse
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
blood pressure
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Respiration
Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Trunk fat percentage
Time frame: Week 25
Trunk fat mass
Time frame: Week 25
Total fat mass
Time frame: Week 25
Visceral adipose tissue (VAT)
Time frame: Week 25
Lean body mass (LBM)
Time frame: Week 25
Bone mineral density (BMD)
Time frame: Week 25
Quality of life score (QoL score)
Time frame: Week 25
BMI
Time frame: Week1Day1,Week25Day1
Change from baseline in waist-to-hip ratio
Time frame: Week3Day1,Week25Day1
IGF-I /IGFBP-3
Time frame: Week1Day1,Week25Day1
Cmax
Time frame: Week1Day1,Week25Day1
Cmin
Time frame: Week1Day1,Week25Day1
Tmax
Time frame: Week1Day1,Week25Day1
AUC0-t
Time frame: Week1Day1,Week25Day1
AUC0-∞
Time frame: Week1Day1,Week25Day1
AUC0-tau
Time frame: Week1Day1,Week25Day1
Rac_Cmax
Time frame: Week1Day1,Week25Day1
Rac_AUC0-tau
Time frame: Week1Day1,Week25Day1
CL/F
Time frame: Week1Day1,Week25Day1
Vz/F
Time frame: Week1Day1,Week25Day1
DF
Time frame: Week1Day1,Week25Day1
t1/2
Time frame: Week1Day1,Week25Day1
ADA
Time frame: Week1Day1,Week29Day1
NAb
Time frame: Week1Day1,Week29Day1