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Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

NCT07082842 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2026-04-21

No results posted yet for this study

Summary

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

HEC585

HEC585 tablet, taken once daily

DRUG

Placebo

HEC585 Simulation Board, taken once daily

DRUG

Pirfenidone

Pirfenidone, taken three times a day

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2031-01-15
Completion
2032-02-15
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082842 on ClinicalTrials.gov