What this study is
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's being tested
- INS018_055
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Study details
- Official title
- 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)
- Sponsor
- InSilico Medicine Hong Kong Limited
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Enrolling
- 40 people
- Starts
- 2024-02-08
- Est. completion
- 2026-02-28
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- 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
- Meeting all of the following criteria during the screening period:; FVC ≥40% predicted normal; DLCO corrected for Hgb ≥25% and <80% predicted normal; Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value
You can't join if
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
12 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
RecruitingHonorHealth Research Institute
Scottsdale, Arizona, United States
RecruitingKeck School of Medicine of USC
Los Angeles, California, United States
RecruitingFlorida Lung Asthma and Sleep Specialist
Celebration, Florida, United States
RecruitingCentral Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando, Florida, United States
RecruitingSoutheastern Research Center
Winston-Salem, North Carolina, United States
RecruitingUniversity of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, United States
RecruitingTemple University Hospital-Temple Lung Center
Philadelphia, Pennsylvania, United States
RecruitingBogan Sleep Consultants, LLC
Columbia, South Carolina, United States
RecruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RecruitingMetroplex Pulmonary and Sleep Center
McKinney, Texas, United States
RecruitingResearch Centers of America
McKinney, Texas, United States
Recruiting
Study team
Sponsor
InSilico Medicine Hong Kong Limited
Study ID INS018-055-004
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.