A 6-month prospective, randomized, double-blind, placebo-controlled clinical trialinvestigating the efficacy, safety and tolerability of two different doses of buntanetap orplacebo

This project is a six-month prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of buntanetap compared with placebo. The trial’s central objective is to generate rigorous, controlled evidence to determine whether buntanetap, administered at two dosing levels, produces clinically meaningful benefits while maintaining an acceptable safety and tolerability profile over a six-month treatment period. By employing a randomized and double-blind design with placebo control, the study aims to minimize bias and placebo effects and to provide high-quality data supporting clear interpretation of outcomes.

Tolerability will be assessed through both participant-reported measures and investigator assessments, capturing the frequency, severity, and impact of treatment-emergent symptoms that could influence adherence or quality of life. The dual-dose design enables exploration of dose–response relationships, informing whether a higher or lower dose optimizes the therapeutic index—maximizing benefit while minimizing adverse effects.