Study ID: MAA868
A dose-range finding study of MAA868 in patients with atrial fibrillation
Researchers are studying the experimental medication MAA868, an antibody that may prevent and treat thrombosis without increasing the risk of excessive bleeding. Eligible participants are those who have been diagnosed with paroxysmal atrial fibrillation or atrial flutter.
Participants are randomized into two study arms. Those in Arm 1 receive injection of MAA868 on the first day and then two subsequent monthly injections. Within this group:
- Cohort 1 receives a low dose of MAA868
- Cohort 2 receives a high dose
- Cohort 3 receives a dose to be determined by the clinician
Participants who are randomized into Arm 2 receive a placebo.
This study is a multicenter, randomized, dose-ranging study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of the experimental medication MAA868 in patients with atrial fibrillation or flutter and at low risk of thromboembolic stroke or peripheral embolism.
MAA868 is a fully human antibody that binds the catalytic domain of zymogen and activated reducing factor XI (FXI). It is being studied as a means to prevent and treat thrombosis with a minimal risk of bleeding.
The primary objective of this study is to determine inhibition of FXI at trough after third dose (day 91) at different dose levels of MAA868.
- Must have been diagnosed with paroxysmal atrial fibrillation or atrial flutter
- Must not have had a stroke, transient ischemic attack or systemic embolism
- Must not have a history of major bleeding during treatment with an anticoagulant or antiplatelet therapy, or a family history of a bleeding disorder
Other inclusion and exclusion criteria apply.