Recruiting
Phase 2

INS018_055

Sponsor:

InSilico Medicine Hong Kong Limited

Code:

NCT05975983

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

INS018_055

Placebo

Study Details

Brief summary:

The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Study ID

NCT05975983

Start date

Feb 8, 2024

Status verified date

Nov, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form
2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
4. Meeting all of the following criteria during the screening period:

1. FVC ≥40% predicted normal
2. DLCO corrected for Hgb ≥25% and <80% predicted normal
3. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INS018 055

INS018\_055 is administered once daily up to 12 weeks

placebo comparator: Placebo

Placebo is administered once daily up to 12 weeks

Interventions

INS018 055

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Placebo

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Primary outcome measure

  • Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) [ Time Frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT)) ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Keck School of Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Florida Lung Asthma and Sleep Specialist

Recruiting

Celebration, Florida, United States, 34747-1818

Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando

Recruiting

Orlando, Florida, United States, 32803-5727

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103-4007

University of Oklahoma Health Sciences Center (OUHSC)

Recruiting

Oklahoma City, Oklahoma, United States, 73104-5417

Temple University Hospital-Temple Lung Center

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Bogan Sleep Consultants, LLC

Recruiting

Columbia, South Carolina, United States, 29201-2953

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235-6243

Metroplex Pulmonary and Sleep Center

Recruiting

McKinney, Texas, United States, 75069-1898

Research Centers of America

Recruiting

McKinney, Texas, United States, 75071

More Information

Sponsor

InSilico Medicine Hong Kong Limited

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis
  • Fibrosis
  • Pathologic Processes
  • Lung Diseases, Interstitial
  • Lung Diseases
  • Respiratory Tract Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by InSilico Medicine Hong Kong Limited on 2025-11-12.