U.S., March 5 -- ClinicalTrials.gov registry received information related to the study (NCT07450001) titled 'A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)' on Feb. 12.
Brief 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(R) in children with GHD. It will also evaluate PK/PD profile ...