drugset / Trial / NCT07551804

Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency

NCT07551804

Phase 2 Not yet recruiting 36 enrolled Xiamen Amoytop Biotech Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.

Timeline

Start
2026-05-31
Primary completion
2027-12-31
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Inpegsomatropin Protein / enzyme biologic 1 mg Subcutaneous
Subject Inpegsomatropin Protein / enzyme biologic 2 mg Subcutaneous
Subject Inpegsomatropin Protein / enzyme biologic 4 mg Subcutaneous

Indications