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Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised,...

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[ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs of mul8ple inhales doses of Rpl554 administered by nebuliser to healthy male subjetc and stable COPS pa8ents Singh D, Abbo>-Banner KH, Reid F, Newman K Mesa 4

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Page 1: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

[ATS]AphaseI,randomised,doubleblind,placebocontrolled,studytoassessthesafety,tolerabilityandpharmacokine8csofmul8pleinhalesdosesofRpl554administeredby

nebulisertohealthymalesubjetcandstableCOPSpa8ents

SinghD,Abbo>-BannerKH,ReidF,NewmanK

Mesa4

Page 2: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

Introducción

Rpl554esuninhibidordelaPPDE3/4.

Víainhalada.

Acciónbroncodilatadora,an8nflamatoriaybroncoprotectora(Franciosietal.2013).

DosisenascensodelfármacoensanosyEPOC(suspensiónapHneutro).

Page 3: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

Métodos

Varonessanosde18a50años.

EPOCde40a75añosconEPOCmoderadoFEV150-80%(selesre8raronBD,peronoCI.

3gruposEPOCysanos:

1,5mg(n=7)2/24hvs.Placebo(n=3) 6mg(n=7)2/24hvs.Placebo(n=3)

12mg(n=7)2/24hvs.Placebo(n=3)

Seguimientoduranteusodemedicación(7días)yhasta10díasdespués.

Page 4: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

ResultadosBientolerado.

Efectosadversossimilaresaplacebo(adosisaltas:taquicardia).(TA,ECG,Holter).

Farmacociné8ca:vidamedia10-12h.

Page 5: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

Conclusiones

Rpl554bientoleradoadosis8-16vecessuperioresquealasquedemostróefectosBDyan8nflamatoriosinvitro.

EfectobroncodilatadorenpacientesconEPOC.

Administración2vecesaldía.

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