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

NCT04233814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-03-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rein Therapeutics

    lead INDUSTRY

Principal Investigators

  • Devinda Weeraratne, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-12-23
Completion
2021-12-23
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233814 on ClinicalTrials.gov