This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation to assess safety, tolerability, PK/PD profile, and immunogenicity of GenSci134 in children with GHD.
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 GHD. It will also evaluate PK/PD profile and immunogenicity to support dose selection for Phase III.
Informed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.
BMI within the range of ±2 SD of the mean BMI for age and sex at screening
Height is at least 2 SD below the mean HT for age and sex (HT SDS ≤ -2.0) at screening according to the normal pediatric population standards
Diagnosis of GHD confirmed by two different GH stimulation tests performed at screening or within 12 months prior to screening.
Presence of one or more pituitary hormone deficiencies in addition to growth hormone deficiency.
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: 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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