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

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.

Start Date06 Mar 2026

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

NCT07450001

/ Not yet recruitingPhase 1/2

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

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.

Start Date06 Mar 2026

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

NCT07016802

/ RecruitingPhase 1

A Randomized, Double-Blind, Placebo and Positive Drug-Controlled, Single-Dose, Dose-Escalation Phase I Clinical Study of GenSci134 Injection in Healthy Adults

To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers

Start Date23 Jun 2025

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

100 Clinical Results associated with GenSci134

100 Translational Medicine associated with GenSci134

100 Patents (Medical) associated with GenSci134

100 Deals associated with GenSci134

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Growth hormone deficiency	Phase 2	China	Changchun Genescience Pharmaceuticals Co., Ltd.	23 Jan 2026
Idiopathic short stature	Phase 2	China	Changchun Genescience Pharmaceuticals Co., Ltd.	16 Jan 2026

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