Phase 2 Study of Inpegsomatropin Injection to Assess Safety and Effectiveness in Adult Men With Growth Hormone Deficiency

What this Trial Is About

Researchers are conducting a phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of Inpegsomatropin Injection in adult males with growth hormone deficiency. This randomized, double-blind, placebo-controlled study enrolls 36 participants in ascending dose groups to assess the investigational treatment compared to placebo. The trial is sponsored by Xiamen Amoytop Biotech Co., Ltd. and aims to gather detailed safety and response information in this population. Participants will receive weekly subcutaneous injections of either Inpegsomatropin Injection or matching placebo at low, middle, or high doses, depending on their assigned dose cohort. The study uses a sequential design with randomization in a 31 ratio within each dose group. The dosing schedules and placebo controls are maintained throughout the treatment period to carefully monitor effects and compare outcomes across different dosage levels. Throughout the trial, participants will undergo extensive monitoring including adverse event assessment, vital signs, laboratory tests, imaging exams, body composition measures, and quality of life evaluations at multiple time points from baseline up to 37 weeks. Blood samples will be collected to analyze pharmacokinetics and immunogenicity markers. These evaluations aim to measure safety signals, body changes, hormone levels, and other health parameters to understand the treatments impact over time. The total study duration includes screening, treatment, and follow-up visits with detailed data collection scheduled at regular intervals.

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