U.S., March 5 -- ClinicalTrials.gov registry received information related to the study (NCT07450053) titled 'A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)' 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 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 ...