254PD101: Phase 1 Study BIIB094 Administered Intrathecally to Adults

• Research type

  Research Study

• Full title

  A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease

• IRAS ID

  266569

• Contact name

  Professor Huw Morris

• Contact email

  h.morris @ucl.ac.uk

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2018-002995-42

• Duration of Study in the UK

  2 years, 8 months, 0 days

• Research summary

  This is a first-in-human Phase 1 study which will evaluate the safety, tolerability and pharmacokinetic (PK) profile of BIIB094 (study drug) administered via intrathecal injection (an injection into the spinal canal) to participants with Parkinson’s Disease.

  The purpose of this study is to see how safe and well-tolerated the study drug is when given to people with Parkinson's Disease (PD). There are two parts to this study, Part A and Part B. In Part A participants will be randomised to receive a single dose of the study drug (10mg, 30mg, 80mg, and 150mg) or a placebo in a 3:1 ratio.

  After Part A has finished Part B will begin. Participants could be in Part A, Part B, or both. Four different study drug levels will be tested (between 40mg and 150mg), the exact dose levels will be decided based on the study results gathered at that point. Participants will be randomised to study drug: placebo in a 3:1 ratio.

  Study duration for Part A will be approx. 18 weeks, Part B up to 47 weeks and for those who enrol in both Parts a minimum of 62 weeks.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0349

• Date of REC Opinion

  24 Sep 2019

• REC opinion

  Further Information Favourable Opinion