drugset / Trial / NCT07600021

A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis

NCT07600021 ↗

Phase 2 Not yet recruiting 156 enrolled InnovStone Therapeutics Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It Aims aims to evaluate the efficacy and safety of different doses of SYH2059 tablets compared with placebo in adult patients with IPF, observe the PK profile of SYH2059 tablets in adult IPF patients, and assess the population pharmacokinetic (PPK) profile, exposure-response (E-R) relationship, as well as the changing trends of blood biomarkers.

Timeline

Start
2026-06-30
Primary completion
2027-10-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SYH2059 Unknown 1.5 mg —
Subject SYH2059 Unknown 3 mg —
Subject SYH2059 Unknown 6 mg —