Phase I Trial (QSC300320)
Research type
Research Study
Full title
A Phase I Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ciraparantag for Reversal of Supratherapeutic Doses of Anticoagulants in Healthy Adults
IRAS ID
1006328
Contact name
Lucy Clayton
Contact email
Sponsor organisation
Norgine Ltd.
Eudract number
2022-002756-39
ISRCTN Number
ISRCTN28849775
Research summary
The Sponsor is developing the test medicine, ciraparantag, for situations when the effects of a commonly prescribed type of oral anticoagulant drugs (blood thinners) need to be reversed quickly.\n\nThis healthy volunteer study will evaluate the efficacy and safety of a single intravenous (IV, administered via injection into a vein) dose of the test medicine for reversal of anticoagulation (blood thinning) that has been caused by three different oral anticoagulant drugs.\n\nThis study will take place at 1 non-NHS site, enrolling up to 126 healthy male and non-pregnant, non-lactating female volunteers aged between 18 and 55 years. \n\nThree separate groups of volunteers will receive one of the three different oral anticoagulant drugs on Day 1 to Day 4 of the study. The test medicine or placebo (dummy drug) will be given on Day 4 to test whether it reverses the anticoagulant effect. Volunteers will have a 2:1 chance of getting the test medicine versus the placebo. The study is blinded, which means the volunteers and study team will not know which volunteers have received the test medicine and which volunteers have received the placebo. A further 3 groups of volunteers may be given a different dose of the test medicine depending on the effect seen in the first three groups.\n\nVolunteers will be discharged on Day 6 at the earliest, or when the discharge criteria are met, and return for a follow up visit 3 to 5 days later.\n\nVolunteers will have different tests (including some blood and urine tests) throughout the study for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this study for approximately 6 weeks from screening to the follow up visit.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0294
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion