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Caveolin-1-Scaffolding-Protein-D…

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

Ensayo de Rein Therapeutics, Inc. en Fibrosis pulmonar idiopatica.

Más ensayos de: Fibrosis pulmonar idiopática.

Fase

Fase 1

Estado

Completado

Participantes

71

previstos

Centros

1

Fin del objetivo primario

dic 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2020.

Qué mide

Incidence of Treatment-Emergent Adverse Events (TEAE) (del registro, en inglés) (hasta 49 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

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Todos los de RNTX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04233814), actualizada en mar 2022.