NCT04233814

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Rein Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)	LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler.
DRUG	Placebo	Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler.

Timeline

• Start date: 2020-01-20
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2020-01-18
• Last updated: 2022-03-07

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study