A phase 1b/2 study of DS-1040b in patients with acute ischaemic stroke
Research type
Research Study
Full title
A Phase 1b/2, multi-center, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebo-controlled, randomized, single-ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.
IRAS ID
194200
Contact name
Kimberly Stranick
Contact email
Sponsor organisation
Daiichi Sankyo Inc
Eudract number
2015-001824-43
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
115473 , IND number
Duration of Study in the UK
0 years, 8 months, 4 days
Research summary
Acute ischaemic stroke (AIS) is the sudden loss of blood circulation to an area of the brain, often caused by a blood clot, which leads to the loss of neurologic functions (such as loss of movement, speech, vision, comprehension, etc.). \n \nThe study drug is an inhibitor of the activated form of thrombin activated fibrinolysis (TAFIa) inhibitor intended to be used for the treatment of disease such as AIS. When a stroke happens, a natural molecule called TAFIa in the body slows down the dissolution of the blood clot. The study drug is an inhibitor of this molecule and helps to dissolve the blood clot that causes the stroke.\n\nThe Aim of this study is to:\n•Look at the safety of a single dose of DS-1040b\n•Determine how the study drug is distributed, chemically broken down and removed from the body by looking at the blood and urine levels of the study drug; \n•Assess if the study drug has an effect on the blood clot in the participant’s brain;\n•Determine if the study drug affects the neurological symptoms and recovery.\n\nThis is an early phase study, which means the study drug will be given to a small group of participants with AIS. This study will enrol men and women between the ages of 18 and 80 years who have had stroke symptoms within the last 3 to 8 hours before receiving the study drug. Approximately 80 to 96 participants will take part in the study at multiple sites in the United States (US) and in countries in Europe.\n\nParticipants will be invited to take part in this study because they have had (or may of had) an ischaemic stroke with symptoms within the last 3 to 8 hours.\nDaiichi Sankyo Inc (referred to as the Sponsor) is the Sponsoring Company conducting this research.\n\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0628
Date of REC Opinion
21 Oct 2016
REC opinion
Further Information Favourable Opinion