Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

NCT05975983 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INS018-055-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

Brief Summary

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

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)

  Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))

Secondary Outcomes (19)

• Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

  Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

• Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

  Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

• Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

  Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

• Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

  Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

• Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

  Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

Study Arms (2)

INS018_055

EXPERIMENTAL

INS018\_055 is administered once daily up to 12 weeks

Drug: INS018_055

Placebo

PLACEBO COMPARATOR

Placebo is administered once daily up to 12 weeks

Drug: Placebo

Interventions

INS018_055 DRUG

Pharmaceutical formulation: Tablet Mode of Administration: Oral

INS018_055

Placebo DRUG

Pharmaceutical formulation: Tablet Mode of Administration: Oral

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• InSilico Medicine Hong Kong Limited: lead

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

Florida Lung Asthma and Sleep Specialist

Celebration, Florida, 34747-1818, United States

RECRUITING

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

Orlando, Florida, 32803-5727, United States

RECRUITING

Southeastern Research Center

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

RECRUITING

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, 73104-5417, United States

RECRUITING

Temple University Hospital-Temple Lung Center

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201-2953, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75235-6243, United States

RECRUITING

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069-1898, United States

RECRUITING

Research Centers of America

McKinney, Texas, 75071, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Central Study Contacts

Monique Duncan

CONTACT

+86 18817554306; Insilico-Clinicaltrial@insilico.ai

Carol Salter, MD, PhD

CONTACT

Insilico-Clinicaltrial@insilico.ai

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: February 8, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)