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

  • STATUS
    Recruiting
  • participants needed
    72
  • sponsor
    Lung Therapeutics, Inc
Updated on 28 January 2022
body mass index
COPD
pulmonary disease

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.

Details
Condition usual interstitial pneumonia, Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
Treatment Placebo, Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)
Clinical Study IdentifierNCT04233814
SponsorLung Therapeutics, Inc
Last Modified on28 January 2022

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