Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
InSilico Medicine Hong Kong Limited
Study ID
NCT05975983
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INS018_055 — DRUG
    Pharmaceutical formulation: Tablet Mode of Administration: Oral
  • Placebo — DRUG
    Pharmaceutical formulation: Tablet Mode of Administration: Oral

Study Details

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).

Key Dates

Start date
Feb 8, 2024
Status verified
Nov 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INS018_055
    INS018\_055 is administered once daily up to 12 weeks
  • Placebo Comparator: Placebo
    Placebo is administered once daily up to 12 weeks

Primary Outcome Measure

Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) [ Time Frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT)) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
HonorHealth Research InstituteScottsdaleArizona85258-
Keck School of Medicine of USCLos AngelesCalifornia90033-
Florida Lung Asthma and Sleep SpecialistCelebrationFlorida34747-1818-
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown OrlandoOrlandoFlorida32803-5727-
Southeastern Research CenterWinston-SalemNorth Carolina27103-4007-
University of Oklahoma Health Sciences Center (OUHSC)Oklahoma CityOklahoma73104-5417-
Temple University Hospital-Temple Lung CenterPhiladelphiaPennsylvania19140-
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201-2953-
University of Texas Southwestern Medical CenterDallasTexas75235-6243-
Metroplex Pulmonary and Sleep CenterMcKinneyTexas75069-1898-
Research Centers of AmericaMcKinneyTexas75071-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALHonorHealth Research Institute· Scottsdale, AZKeck School of Medicine of USC· Los Angeles, CAFlorida Lung Asthma and Sleep Specialist· Celebration, FLCentral Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando· Orlando, FLSoutheastern Research Center· Winston-Salem, NC

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