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NOT YET RECRUITING
NCT07600021
PHASE2

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

Sponsor: InnovStone Therapeutics Limited

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-06-30

Completion Date

2027-12-30

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

SYH2059 Tablets

Take twice daily, about 12 hours apart, after meals, for 12 weeks.

DRUG

Placebo

Take twice daily, about 12 hours apart, after meals, for 12 weeks.