Calendario›KRYS›KB407

KB407

A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis

Ensayo de Krystal Biotech, Inc. en Fibrosis quistica.

Más ensayos de: Fibrosis quística.

Fase

Fase 1

Estado

Retirado antes de empezar

Centros

1

Fin del objetivo primario

jul 2024

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Pandemic, logistical, and recruitment challenges».

Qué mide

To evaluate the safety and tolerability of KB407 in subjects with Cystic Fibrosis through adverse events as assessed by NCI-CTCAE v5.0 (Baseline to End of the treatment assessed up to an average of 60 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) to the airways of people with cystic fibrosis via nebulization. This study is designed to evaluate safety and tolerability of KB407 in people with cystic fibrosis. This study will enroll 4 participants into each of the first two cohorts and will enroll five subjects into the last cohort. Cohort 1 will receive a single dose of KB407 and be followed for 60 days. Subjects in Cohort 1 may rollover into Cohort 2 at the Day 28 Visit. A Data Safety Monitoring Board (DSMB) will meet to determine study progress from Cohort 2 into Cohort 3. In Cohort 2, subjects will be dosed bi-weekly at Day 0 and Day 14. In Cohort 3 subjects will be dosed weekly at Day 0, Day 7, Day 14 and Day 21. All subjects will be followed for a year after the last dose of KB407.

Más ensayos de KRYS

Todos los de KRYS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05095246), actualizada en ago 2023.