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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

RecruitingPhase 2

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)

Who can join

Ages 40 and older · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: InSilico Medicine Hong Kong Limited · Participants: 40 · Started: Feb 8, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05975983

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArizonaHonorHealth Research Institute, Scottsdale
CaliforniaKeck School of Medicine of USC, Los Angeles
FloridaFlorida Lung Asthma and Sleep Specialist, Celebration
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando, Orlando
North CarolinaSoutheastern Research Center, Winston-Salem
OklahomaUniversity of Oklahoma Health Sciences Center (OUHSC), Oklahoma City
PennsylvaniaTemple University Hospital-Temple Lung Center, Philadelphia
South CarolinaBogan Sleep Consultants, LLC, Columbia
TexasUniversity of Texas Southwestern Medical Center, Dallas
Metroplex Pulmonary and Sleep Center, McKinney
Research Centers of America, McKinney

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.