Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

The current study will investigate the initial safety, tolerability, and PK profile of inhaled LTI-03 in healthy volunteers. In order to minimize exposure, the study will first test single ascending doses (SAD) of LTI-03 followed by multiple ascending dose (MAD) cohorts.

Findings from this study will direct the clinical development of LTI-03 for the treatment of IPF

The study subject population will include normal healthy male and female volunteers between 18 and 55 years of age (inclusive).

Consistent with other trials involving inhaled medication, subjects must have normal pulmonary function at Screening and will be excluded if they have a history of active or recurring allergies, asthma, chronic obstructive pulmonary disease (COPD), chronic sinus drainage, chronic or acute cough or other respiratory condition deemed exclusionary by the Investigator. History of liver dysfunction or elevated bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values at Screening will also be grounds for exclusion.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT04233814
• Study type: Interventional
• Source: Lung Therapeutics, Inc
• Status: Completed
• Phase: Phase 1
• Start date: January 20, 2020
• Completion date: December 23, 2021