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โ† Trials
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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

RecruitingPhase 2Ages 40 Years - anyAllInSilico Medicine Hong Kong Limited
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female patients aged โ‰ฅ40 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 โ‰ฅ40% predicted normal 2. DLCO corrected for Hgb โ‰ฅ25% 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
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What it tests

  • INS018_055
  • Placebo
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Where

12 sites
University of Alabama at Birmingham
Birmingham, United States
HonorHealth Research Institute
Scottsdale, United States
Keck School of Medicine of USC
Los Angeles, United States
Florida Lung Asthma and Sleep Specialist
Celebration, United States
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando, United States
Southeastern Research Center
Winston-Salem, United States
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, United States
Temple University Hospital-Temple Lung Center
Philadelphia, United States

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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