This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase â…¡a 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.
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Adverse Event
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Serious Adverse Event
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of Participants with Abnormal Laboratory Parameters Findings
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
HR (bpm)
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
PR (ms)
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QRS (ms)
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QT (ms)
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QTc (ms)
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of participants with clinically significant changes in imaging examinations
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body weight
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body Mass Index
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body temperature
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
pulse
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
blood pressure
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Respiration
Timeframe: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Trunk fat percentage
Timeframe: Week 25
Trunk fat mass
Timeframe: Week 25
Total fat mass
Timeframe: Week 25
Visceral adipose tissue (VAT)
Timeframe: Week 25
Lean body mass (LBM)
Timeframe: Week 25
Bone mineral density (BMD)
Timeframe: Week 25
Quality of life score (QoL score)
Timeframe: Week 25
BMI
Timeframe: Week1Day1,Week25Day1
Change from baseline in waist-to-hip ratio
Timeframe: Week3Day1,Week25Day1
IGF-I /IGFBP-3
Timeframe: Week1Day1,Week25Day1
Cmax
Timeframe: Week1Day1,Week25Day1
Cmin
Timeframe: Week1Day1,Week25Day1
Tmax
Timeframe: Week1Day1,Week25Day1
AUC0-t
Timeframe: Week1Day1,Week25Day1
AUC0-∞
Timeframe: Week1Day1,Week25Day1
AUC0-tau
Timeframe: Week1Day1,Week25Day1
Rac_Cmax
Timeframe: Week1Day1,Week25Day1
Rac_AUC0-tau
Timeframe: Week1Day1,Week25Day1
CL/F
Timeframe: Week1Day1,Week25Day1
Vz/F
Timeframe: Week1Day1,Week25Day1
DF
Timeframe: Week1Day1,Week25Day1
t1/2
Timeframe: Week1Day1,Week25Day1
ADA
Timeframe: Week1Day1,Week29Day1
NAb
Timeframe: Week1Day1,Week29Day1