This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and immunogenicity of a single subcutaneous dose of GenSci134 in children with idiopathic short stature (ISS).
Phase II is a multicenter, randomized, open-label, active-controlled, multiple-dose, parallel-group study to assess the efficacy and safety of multiple subcutaneous doses of GenSci134 at different levels versus Norditropin® in children with ISS. It will also evaluate PK/PD profile, immunogenicity, and biomarkers to support dose selection for Phase III.
sInformed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.
Diagnosis of ISS at the time of ICF signing .
BMI within the range of ±2 SD of the mean BMI for age and sex at screening（Phase II only）.
No prior exposure to GH or IGF-1 therapy.
GHD.
Turner Syndrome.
Noonan syndrome.
Laron Syndrome.
Sequential
GenSci134 Injection
Drugonly one dose of GenSci134 to be given, subcutaneous , 6 dose levels will be assigned.
Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
Drugmultiple doses of Norditropin® FlexPro® quaque die (QD) for 28 consecutive days by subcutaneous injections.
Phase Ib: Incidence of Treatment Emergent Adverse Events （TEAEs）
Phase II: Annualized height velocity (AHV) at Week 24 of treatment
Phase Ib: Areas under the drug concentration-time curve (AUC0-t, AUC0-∞) of GenSci134
Phase Ib: Time to maximum concentration (Tmax) of GenSci134
Phase Ib: Maximum concentration (Cmax) of GenSci134
Phase Ib: Half-life (t1/2) of GenSci134
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