Single Ascending Dose, Safety, Tolerability and PK Study of PQ1228

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PQ1228 in Healthy Male and Female Subjects

• IRAS ID

  117453

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Probiodrug AG

• Eudract number

  2012-004934-40

• ISRCTN Number

  N/A

• Research summary

  This is the first time PQ1228 will be given to humans. Healthy subjects will receive Study drug or placebo (dummy tablet). The subjects and staff will not know which treatment the subjects have been given i.e. they are blinded, except for 3 groups (Cohorts 11, 91 and 92), in which all subjects will receive the study drug. The study will investigate the safety, tolerability, levels of study drug in the blood stream and, in some subjects, levels of the drug iflud taken from the spine (CSF or cerebrospinaflud which surrounds the brain and spinal cord). The effect of food on levels of study drug in the blood will also be investigated. Cohort 11 will include 3 subjects treated with PQ1228. Cohorts 12 ?? 17 will each include 6 subjects treated with PQ1228 and 2 with placebo. Cohorts 12 ?? 17 will include sentinel dosing: 2 subjects will be dosed with PQ1228 and 1 subject with placebo on one day and then, at least 48 hours later, a further 4 subjects will be dosed with PQ1228 and 1 subject with placebo. Cohorts 91 (food effect) and 92 (CSF sampling) will each include 6 subjects treated with PQ1228. The study is expected to include 55 - 71 healthy subjects in total. Subjects will be confined to the Research Unit from the day before the dosing day (Day -1) until two days after the dosing day (Day 3). CSF sampling will be performed in Cohorts 13 and 92. Three 3ml samples will be taken from each subject at times to be decided on based on the results of blood levels of PQ1228 obtained in earlier cohorts. Cohorts 11 ?? 13 will be completed in the Covance, Basel unit, Switzerland. Cohorts 14 onwards will be dosed in Leeds.

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0407

• Date of REC Opinion

  13 Dec 2012

• REC opinion

  Favourable Opinion