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Molgramostim

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Ensayo de Savara Inc en Pulmonary Alveolar Proteinosis · Bronchiectasis · Cystic Fibrosis · Acute Respiratory Distress Syndrome (del registro, en inglés).

Más ensayos de: Fibrosis quística.

Fase

Fase 1

Estado

Completado

Participantes

42

previstos

Centros

1

Fin del objetivo primario

oct 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2015.

Qué mide

Number and severity of treatment-emergent Adverse Events (AEs) following single and multiple inhaled doses of molgramostim (1-6 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male and female subjects (on non-child bearing potential) will be enrolled to investigate single inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The Clinical trial will involve 42 healthy participants. The trial is expected to last approximately 4 months.

Más ensayos de SVRA

Todos los de SVRA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02468908), actualizada en feb 2017.