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

Sponsor
InnovStone Therapeutics Limited
Study ID
NCT07600021
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYH2059 Tablets — DRUG
    Take twice daily, about 12 hours apart, after meals, for 12 weeks.
  • Placebo — DRUG
    Take twice daily, about 12 hours apart, after meals, for 12 weeks.

Study Details

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.

Key Dates

First listed
May 20, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose group
    SYH2059 tablets were administered twice daily at 6mg after meals for 12 weeks.
  • Experimental: Medium-dose group
    SYH2059 tablets were administered twice daily at 3mg after meals for 12 weeks.
  • Experimental: Low dose group
    SYH2059 tablets were administered twice daily at 1.5 mg after meals for 12 weeks.
  • Placebo Comparator: Placebo group
    Placebo tablets were administered twice daily at 1.5 mg after meals for 12 weeks.

Primary Outcome Measure

Change in FVC from baseline (mL) [ Time Frame: Week 12 ]

Central Contacts

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