This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
28
Subcutaneous injection: low dose
Subcutaneous injection: high dose
Subcutaneous injection: Dose to be determined.
Anthos Investigative Site
Beverly Hills, California, United States
Anthos Investigative Site
Wichita, Kansas, United States
Anthos Investigative Site
Alexandria, Louisiana, United States
Anthos Investigative Site
Lansing, Michigan, United States
Number of Participants That Achieved More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After the Third Dose (Day 91) at Different Dose Levels of MAA868
Number of participants achieving more than or equal to 50%, 80%, and 90% inhibition of factor XI (less than 50%, 20%, or 10% free factor XI) at trough after the third dose on Day 91 at different dose levels of MAA868
Time frame: Day 91
Number of Participants Achieving More Than or Equal to 50%, 80%, and 90% Factor XI Inhibition at Trough After First (Day 31) and Second Doses (Day 61) at Different Dose Levels of MAA868
Number of participants achieving more than or equal to 50%, 80%, and 90% inhibition of factor XI (less than 50%, 20%, or 10% free factor XI) at trough on Day 31 (after first dose) and Day 61 (after second dose) at different dose levels of MAA868
Time frame: Day 31 and Day 61
Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study
Overall number of participants who experienced adverse events following multiple subcutaneous administration of MAA868 compared to placebo in participants with atrial fibrillation or atrial flutter
Time frame: Day 1 through end of study, up to 170 days
Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo
Occurrence of confirmed major bleeding events, clinically relevant non-major bleeding events and total bleeding events during the treatment period
Time frame: Day 1 through end of study, up to 170 days
Immunogenicity of MAA868
Number of participants with anti-drug (MAA868) antibodies for all participants who received MAA868 120 mg or MAA868 180 mg. "Non-evaluable observation" refers to participants who had no sample collected (due to no visit or remote visit) or for whom the sample was not frozen.
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Subcutaneous injection: Placebo
Anthos Investigative Site
Wynnewood, Pennsylvania, United States
Anthos Investigative Site
McKinney, Texas, United States
Time frame: Days 1, 31, 61, 71, 91, 121 and 170