NCT07450001

A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)

A Phase Ib/II Multicenter, Randomized, Open-label, Active-controlled, Single/Multiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Growth Hormone Deficiency

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pediatric Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	GenSci134 Injection	only one dose of GenSci134 to be given, subcutaneous , 6 dose levels will be assigned.
DRUG	Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)	multiple doses of Norditropin® FlexPro® quaque die (QD) for 28 consecutive days by subcutaneous injections.

Timeline

• Start date: 2026-03-06
• Primary completion: 2028-07-18
• Completion: 2028-12-31
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: China