Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Description

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Condition
Idiopathic Pulmonary Fibrosis (IPF)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck School of Medicine of USC, Los Angeles, California, United States, 90033

Celebration

Florida Lung Asthma and Sleep Specialist, Celebration, Florida, United States, 34747-1818

Orlando

Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando, Orlando, Florida, United States, 32803-5727

Winston-Salem

Southeastern Research Center, Winston-Salem, North Carolina, United States, 27103-4007

Oklahoma City

University of Oklahoma Health Sciences Center (OUHSC), Oklahoma City, Oklahoma, United States, 73104-5417

Columbia

Bogan Sleep Consultants, LLC, Columbia, South Carolina, United States, 29201-2953

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75235-6243

McKinney

Metroplex Pulmonary and Sleep Center, McKinney, Texas, United States, 75069-1898

McKinney

Research Centers of America, McKinney, Texas, United States, 75071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for ≥ 8 weeks prior to Visit 1
  • 1. FVC ≥40% predicted of normal
  • 2. DLCO corrected for Hgb ≥25% and \<80% predicted of normal.
  • 3. forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value
  • 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InSilico Medicine Hong Kong Limited,

Study Record Dates

2026-02-28