A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events
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CONTACT
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 or revascularization
QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording
You may not be if
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 days prior to screening Visit 1
History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine 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
Estimated glomerular filtration rate \<50 mL/min/1.73 m² as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of screening.
Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study
Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study
Clareo Health | A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events
