OKL-1111 - first doses in humans
Research type
Research Study
Full title
A randomised, placebo controlled, double-blind, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of OKL-1111 after intravenous doses administered alone or following anticoagulant dabigatran etexilate in healthy subjects.
IRAS ID
1005980
Contact name
Edwin Spaans
Contact email
Sponsor organisation
Alveron Pharma UK Ltd
Eudract number
2022-003463-19
ISRCTN Number
ISRCTN17692710
Research summary
This is a study of an experimental new treatment for excessive bleeding (haemorrhage) caused by anticoagulant therapies (sometimes called ‘blood thinners’). Anticoagulants are important treatments for people who have a high risk of developing blood clots; but, they sometimes cause excessive bleeding, which can be life-threatening. The study medicine is being developed as an ‘antidote’ to reverse the effects of anticoagulants. We hope it will rapidly reverse excessive bleeding caused by many different types of anticoagulants.\n\nThis study is in 2 parts (Parts A and B). In each part, we’ll test single doses of the study medicine (or placebo) in 12 healthy men, aged 18–50 years. The study medicine has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects, blood and urine levels, and its effects on blood clotting. We’ll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. In Part B, we’ll assess the effect of the study medicine on blood clotting when given after a dose of an anticoagulant, called dabigatran.\n\nParticipants in Part A will attend 3 study sessions and take about 9 weeks to finish the study. Participants in Part B will attend 2 study sessions and take about 7 weeks to finish the study. All participants will attend a screening visit, stay on the ward for 2 nights in each study session, and attend a final follow-up visit .\n\nA pharmaceutical company Alveron Pharma UK Ltd is funding the study.\nThe study will take place at 1 centre in London.\n\nSummary of Results\n\nThe summary of results are planned to be published on ISRCTN on 30/11/2024\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0813
Date of REC Opinion
24 Jan 2023
REC opinion
Further Information Favourable Opinion