Phase
Condition
Atherosclerosis
Treatment
Selnoflast
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmed evidence of atherosclerosis
Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan
Stable treatment of atherosclerosis through the use of SOC medications orrevascularization
QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording
Exclusion
Exclusion Criteria:
Individuals with Class III and IV heart failure
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension
Suspected or known immunocompromised state
Planned procedure or surgery during the study and any major surgery within 90 daysprior to screening Visit 1
History of malignancy within 5 years prior to screening, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage Iuterine cancer
Positive test results for hepatitis B (HBV) infection at screening
Positive hepatitis C virus (HCV) antibody test at screening
Positive human immunodeficiency virus (HIV) test at screening
Treatment with any live vaccine within 28 days prior to the first dose of study druguntil the end of the study
Treatment with other non-live vaccines within 14 days prior to the first dose ofstudy drug until the end of the study
Study Design
Connect with a study center
Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
United StatesActive - Recruiting
Amnova Clinical Research
Irvine, California 92604
United StatesActive - Recruiting
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California 91307
United StatesActive - Recruiting
Asha Clinical Research-Munster,Llc
Hammond, Indiana 46324
United StatesActive - Recruiting
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243
United StatesActive - Recruiting
Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington 98036
United StatesActive - Recruiting

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