RecruitingAtherosclerosis

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

Eligible age

18+ yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.

Sponsor: Genentech, Inc.

You may qualify 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 qualify 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