Phase 1 SAD study to assess Safety, Tolerability, PK & PD of ASP6294

• Research type

  Research Study

• Full title

  A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects

• IRAS ID

  191472

• Contact name

  Muna Albayaty

• Contact email

  Muna.Albayaty@parexel.com

• Sponsor organisation

  Astellas Pharma Europe BV (APEB)

• Eudract number

  2014-003451-59

• Duration of Study in the UK

  0 years, 8 months, 9 days

• Research summary

  The new medicine tested in this study is a compound called ASP6294. The Sponsor is developing the study drug for the treatment of bladder pain syndrome.
  The study consists of two parts: Part 1 (ascending intravenous dose) and Part 2 (ascending subcutaneous dose). Subjects will participate in either Part 1 or Part 2. Part 2 will follow Part 1.

  The purpose of the study is to:
  See how safe the study drug is and how well it is tolerated after dosing.
  Investigate how the study drug is taken up and excreted (pharmacokinetics).
  Investigate how the study drug affects the body by monitoring the level of a protein called nerve growth factor (NGF) in the blood.
  Investigate the possible formation of antibodies against the study drug (anti-drug antibodies [ADA]).
  Determine the maximum dose level of the study drug that can be used safely (Maximum tolerated dose).
  Investigate if gender has an effect on the study drug.
  Part 2 will also evaluate the relative bioavailability of ASP6294 when administered subcutaneous.

  This study will recruit healthy young, males and females between the ages of 18 and 55 years (inclusive at screening). A total of approximately 72 subjects (up to a maximum of 96) will take part in the study. Additional subjects may be enrolled in the study should additional doses be needed or additional dose groups be added.
  Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic and pharmacodynamic analysis will be collected. Physical and neurological examinations will be performed.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  15/LO/1798

• Date of REC Opinion

  29 Dec 2015

• REC opinion

  Further Information Favourable Opinion