Actively Recruiting

Phase 2
Age: 40Years +
All Genders
NCT05975983

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Led by InSilico Medicine Hong Kong Limited · Updated on 2025-11-12

40

Participants Needed

12

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 640 years based on the date of the written informed consent form
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by recognized respiratory society guidelines
  • Stable health condition suitable for study participation based on medical history, physical examination, vital signs, ECG, and laboratory evaluation
  • During screening, forced vital capacity (FVC) 640% predicted normal
  • During screening, diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin 625% and <80% predicted normal
  • During screening, forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value
Not Eligible

You will not qualify if you...

  • Acute IPF exacerbation within 4 months prior to study start
  • Unwillingness to refrain from smoking within 3 months prior to screening and throughout the study
  • Female patients who are pregnant or nursing
  • Abnormal ECG findings

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 12 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

HonorHealth Research Institute

Scottsdale, Arizona, United States, 85258

Actively Recruiting

3

Keck School of Medicine of USC

Los Angeles, California, United States, 90033

Actively Recruiting

4

Florida Lung Asthma and Sleep Specialist

Celebration, Florida, United States, 34747-1818

Actively Recruiting

5

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

Orlando, Florida, United States, 32803-5727

Actively Recruiting

6

Southeastern Research Center

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

Actively Recruiting

7

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, United States, 73104-5417

Actively Recruiting

8

Temple University Hospital-Temple Lung Center

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

9

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States, 29201-2953

Actively Recruiting

10

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75235-6243

Actively Recruiting

11

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States, 75069-1898

Actively Recruiting

12

Research Centers of America

McKinney, Texas, United States, 75071

Actively Recruiting

Loading map...

Research Team

M

Monique Duncan

CONTACT

C

Carol Salter, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis | DecenTrialz