Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, flutter, paroxysmal atrial fibrillation, stroke, cardiac arrhythmia
Brief summary
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.
Interventions
BIOLOGICALMAA868 Cohort 1
Subcutaneous injection: low dose
BIOLOGICALMAA868 Cohort 2
Subcutaneous injection: high dose
BIOLOGICALMAA868 Cohort 3
Subcutaneous injection: Dose to be determined.
OTHERPlacebo
Subcutaneous injection: Placebo
Sponsors
Covance
Anthos Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥ 18 and \< 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or * Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory \[e.g. Holter\] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this. * Patients with a Congestive heart failure, Hypertension, Age ( \> 65 = 1 point, \> 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
Exclusion criteria
* History of stroke, transient ischemic attack or systemic embolism * History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.) * History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding * Known bleeding diathesis or any known active bleeding site at screening or baseline * Family history of bleeding disorder * Known active GI lesions predisposing to bleeding events * Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period * Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area \<1.5 cm2) * Patients with a prosthetic heart valve Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 91 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 31 and Day 61 | 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 |
| Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study | Day 1 through end of study, up to 170 days | 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 |
| Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Day 1 through end of study, up to 170 days | Occurrence of confirmed major bleeding events, clinically relevant non-major bleeding events and total bleeding events during the treatment period |
| Immunogenicity of MAA868 | Days 1, 31, 61, 71, 91, 121 and 170 | 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. |
Countries
United States
Participant flow
Recruitment details
No subjects were enrolled in the optional Cohort 3.
Pre-assignment details
28 participants were screened. 5 participants did not meet inclusion/exclusion criteria; 5 eligible participants failed randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subcutaneous injection of placebo on Day 1, Day 31, and Day 61 | 5 |
| MAA868 120 mg Subcutaneous injection of 120 mg MAA868 on Day 1, Day 31, and Day 61 | 6 |
| MAA868 180 mg Subcutaneous injection of 180 mg MAA868 on Day 1, Day 31, and Day 61 | 7 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | MAA868 180 mg | MAA868 120 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 8.34 | 53.8 years STANDARD_DEVIATION 9.24 | 52.2 years STANDARD_DEVIATION 18.79 | 55.1 years STANDARD_DEVIATION 11.81 |
| Age, Customized 18 to 20 | 0 years | 0 years | 1 years | 1 years |
| Age, Customized 21 to 30 | 0 years | 0 years | 0 years | 0 years |
| Age, Customized 31 to 40 | 0 years | 1 years | 0 years | 1 years |
| Age, Customized 41 to 50 | 1 years | 0 years | 0 years | 1 years |
| Age, Customized 51 to 60 | 4 years | 4 years | 2 years | 10 years |
| Age, Customized 61 to 70 | 2 years | 1 years | 2 years | 5 years |
| Age, Customized 71 to 80 | 0 years | 0 years | 0 years | 0 years |
| Age, Customized 81 to 85 | 0 years | 0 years | 0 years | 0 years |
| Body mass index | 30.887 kg/m^2 STANDARD_DEVIATION 8.6754 | 30.392 kg/m^2 STANDARD_DEVIATION 4.7558 | 30.022 kg/m^2 STANDARD_DEVIATION 4.1647 | 30.482 kg/m^2 STANDARD_DEVIATION 6.1179 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 6 Participants | 5 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 175.74 centimeters STANDARD_DEVIATION 8.337 | 174.60 centimeters STANDARD_DEVIATION 11.311 | 182.01 centimeters STANDARD_DEVIATION 5.573 | 177.10 centimeters STANDARD_DEVIATION 8.918 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Weight | 94.933 kg STANDARD_DEVIATION 23.2745 | 91.667 kg STANDARD_DEVIATION 7.1102 | 99.352 kg STANDARD_DEVIATION 13.1715 | 95.072 kg STANDARD_DEVIATION 16.0115 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 4 / 5 | 5 / 6 | 3 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 | 0 / 7 |
Outcome results
Primary
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
Population: Pharmacokinetic/Pharmacodynamic Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | More than or equal to 80% inhibition of factor XI | 0 Participants |
| Placebo | 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 | More than or equal to 50% inhibition of factor XI | 0 Participants |
| Placebo | 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 | More than or equal to 90% inhibition of factor XI | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 80% inhibition of factor XI | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 50% inhibition of factor XI | 2 Participants |
| MAA868 120 mg | 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 | More than or equal to 90% inhibition of factor XI | 0 Participants |
| MAA868 180 mg | 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 | More than or equal to 50% inhibition of factor XI | 4 Participants |
| MAA868 180 mg | 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 | More than or equal to 90% inhibition of factor XI | 0 Participants |
| MAA868 180 mg | 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 | More than or equal to 80% inhibition of factor XI | 1 Participants |
Secondary
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.
Time frame: Days 1, 31, 61, 71, 91, 121 and 170
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Immunogenicity of MAA868 | Day 1 | Negative | 6 Participants |
| Placebo | Immunogenicity of MAA868 | Day 61 | Non-evaluable observation | 3 Participants |
| Placebo | Immunogenicity of MAA868 | Baseline | Negative | 6 Participants |
| Placebo | Immunogenicity of MAA868 | Day 71 | Negative | 4 Participants |
| Placebo | Immunogenicity of MAA868 | Day 1 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 71 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 31 | Negative | 6 Participants |
| Placebo | Immunogenicity of MAA868 | Day 71 | Non-evaluable observation | 2 Participants |
| Placebo | Immunogenicity of MAA868 | Day 91 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 1 | Non-evaluable observation | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 91 | Non-evaluable observation | 1 Participants |
| Placebo | Immunogenicity of MAA868 | Baseline | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 121 | Negative | 5 Participants |
| Placebo | Immunogenicity of MAA868 | Day 91 | Negative | 5 Participants |
| Placebo | Immunogenicity of MAA868 | Day 121 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 31 | Non-evaluable observation | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 121 | Non-evaluable observation | 1 Participants |
| Placebo | Immunogenicity of MAA868 | Baseline | Non-evaluable observation | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 170 | Negative | 6 Participants |
| Placebo | Immunogenicity of MAA868 | Day 61 | Negative | 3 Participants |
| Placebo | Immunogenicity of MAA868 | Day 170 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 31 | Positive | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 170 | Non-evaluable observation | 0 Participants |
| Placebo | Immunogenicity of MAA868 | Day 61 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 170 | Non-evaluable observation | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 91 | Negative | 5 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 31 | Negative | 7 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Baseline | Negative | 7 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Baseline | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Baseline | Non-evaluable observation | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 1 | Negative | 7 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 1 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 1 | Non-evaluable observation | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 31 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 31 | Non-evaluable observation | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 61 | Negative | 6 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 61 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 61 | Non-evaluable observation | 1 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 71 | Negative | 6 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 71 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 91 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 91 | Non-evaluable observation | 2 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 121 | Negative | 5 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 121 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 121 | Non-evaluable observation | 2 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 170 | Negative | 7 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 170 | Positive | 0 Participants |
| MAA868 120 mg | Immunogenicity of MAA868 | Day 71 | Non-evaluable observation | 1 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Nuisance (not clinically relevant) bleeding events | 2 incidence of events |
| Placebo | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Clinically relevant non-major bleeding events | 0 incidence of events |
| Placebo | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Major bleeding events | 0 incidence of events |
| Placebo | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | No bleeding events | 0 incidence of events |
| MAA868 120 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Clinically relevant non-major bleeding events | 0 incidence of events |
| MAA868 120 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Major bleeding events | 0 incidence of events |
| MAA868 120 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Nuisance (not clinically relevant) bleeding events | 1 incidence of events |
| MAA868 120 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | No bleeding events | 1 incidence of events |
| MAA868 180 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Nuisance (not clinically relevant) bleeding events | 1 incidence of events |
| MAA868 180 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Clinically relevant non-major bleeding events | 0 incidence of events |
| MAA868 180 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | Major bleeding events | 0 incidence of events |
| MAA868 180 mg | Incidence of Major Bleeding Events, Clinically Relevant Non-major Bleeding Events and Total Bleeding With MAA868 Relative to Placebo | No bleeding events | 0 incidence of events |
Secondary
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
Population: Pharmacokinetic/Pharmacodynamic Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | More than or equal to 50% factor XI inhibition : Day 31 | 0 Participants |
| Placebo | 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 | More than or equal to 50% factor XI inhibition : Day 61 | 0 Participants |
| Placebo | 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 | More than or equal to 80% factor XI inhibition : Day 31 | 0 Participants |
| Placebo | 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 | More than or equal to 80% factor XI inhibition : Day 61 | 0 Participants |
| Placebo | 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 | More than or equal to 90% factor XI inhibition : Day 31 | 0 Participants |
| Placebo | 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 | More than or equal to 90% factor XI inhibition : Day 61 | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 90% factor XI inhibition : Day 61 | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 50% factor XI inhibition : Day 31 | 1 Participants |
| MAA868 120 mg | 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 | More than or equal to 80% factor XI inhibition : Day 61 | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 90% factor XI inhibition : Day 31 | 0 Participants |
| MAA868 120 mg | 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 | More than or equal to 50% factor XI inhibition : Day 61 | 2 Participants |
| MAA868 120 mg | 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 | More than or equal to 80% factor XI inhibition : Day 31 | 1 Participants |
| MAA868 180 mg | 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 | More than or equal to 50% factor XI inhibition : Day 61 | 5 Participants |
| MAA868 180 mg | 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 | More than or equal to 80% factor XI inhibition : Day 31 | 3 Participants |
| MAA868 180 mg | 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 | More than or equal to 90% factor XI inhibition : Day 61 | 0 Participants |
| MAA868 180 mg | 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 | More than or equal to 80% factor XI inhibition : Day 61 | 1 Participants |
| MAA868 180 mg | 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 | More than or equal to 50% factor XI inhibition : Day 31 | 5 Participants |
| MAA868 180 mg | 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 | More than or equal to 90% factor XI inhibition : Day 31 | 0 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study | 4 Participants |
| MAA868 120 mg | Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study | 5 Participants |
| MAA868 180 mg | Overall Number of Participants Who Experienced Adverse Events, Including Serious Adverse Events, During the Treatment Period and Through End of Study | 3 Participants |