LTI-03 in Recently Diagnosed Idiopathic Pulmonary Fibrosis

Summary

The purpose of this study is to learn more about an investigational drug called LTI-03 in individuals with idiopathic pulmonary fibrosis (IPF). Researchers aim to determine whether LTI-03 is tolerable and has any side effects, as well as how much it is absorbed by the lung via a procedure called a bronchoscopy, a minimally invasive procedure in which a camera is inserted into the lung through the mouth or nose. Participants will be randomly assigned to 1 of 2 treatment groups. One group will receive LTI-03, and the other will receive placebo.


Inclusion Criteria

  • Non-smoker (no use of tobacco products within 6 months prior to dosing) with a negative urine cotinine test at Screening or Day -1
  • Age of 18-55 years (inclusive)
  • Body mass index (BMI) of 18 - 30.5 kg/m2 (inclusive)
  • Body weight > 50 kg
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 1b, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide in Recently Diagnosed, Treatment Naïve Subjects with Idiopathic Pulmonary Fibrosis

Details
Disease Type/Condition

Other

Principal Investigator

Zaman, Tanzira

Age Group

Adult

Phase

I

IRB Number

STUDY00002427

ClinicalTrials.gov ID

NCT04233814

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Zaman, Tanzira

Age Group

Adult

Phase

I

IRB Number

LTI-03-1002

ClinicalTrials.gov ID

NCT04233814

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?