Safety, tolerability, and PK study of inhaled SNSP113

• Research type

  Research Study

• Full title

  A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose(SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP 113 in Healthy Male Subjects (Part A) and Subjects with Stable Cystic Fibrosis (Part B)

• IRAS ID

  233298

• Contact name

  Adrian J Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Celerion on behalf of Synspira

• Eudract number

  2017-002908-27

• Duration of Study in the UK

  0 years, 9 months, 7 days

• Research summary

  This is a multi-site, randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study to be conducted in up to 32 healthy adult participants and 9 adult patients with Cystic Fibrosis. Participants will receive a single dose of SNSP113 or placebo. In Part A, four ascending dose levels will be assessed for in healthy male participants. In Part B, three ascending dose levels will be assessed in patients with stable Cystic Fibrosis.
  SNSP113 is a new drug being developed for the treatment of Cystic Fibrosis.

• REC name

  HSC REC A

• REC reference

  17/NI/0152

• Date of REC Opinion

  25 Aug 2017

• REC opinion

  Favourable Opinion