Calendario›SNY›ALX-0171

ALX-0171

ALX-0171 Safety Study in Adults With Hyperresponsive Airways

Ensayo de Sanofi en Respiratory Syncytial Virus Infection (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

24

previstos

Centros

1

Fin del objetivo primario

dic 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2013.

Qué mide

Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation (Within a period of 8 hours post-inhalation) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways. This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum. Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).

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Ficha completa en ClinicalTrials.gov (NCT01909843), actualizada en jul 2018.