Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects
Status:
Recruiting
Trial end date:
2021-12-22
Target enrollment:
Participant gender:
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.