Phase 1 Study of SAR440894 vs Placebo

Exclusion criteria

• . Has any medical condition (renal dysfunction) that, in the opinion of the site PI or appropriate sub-investigator listed on Form Food and Drug Administration (FDA) 1572, is a contraindication to study participation.
• . Has any clinically significant (CS) electrocardiogram (ECG) abnormalities in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator been listed on Form FDA 1572.
• . Use of any prohibited prescription medication (excluding contraceptives in females) within 14 days before study product administration, through Day 56\*\* \*Prohibited medications include immunosuppressives; immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); prescription Non-Steroidal Anti-inflammatory Drugs (NSAIDs); anti-neoplastic agents; any vaccine (licensed or investigational). If study activities overlap with the influenza season, subjects will be instructed to obtain influenza vaccine at least 45 days prior to proposed dosing or delay vaccination until after Day 56. Subjects will be instructed to obtain the last dose of any vaccine for SARS-CoV-2 (COVID-19) at least 45 days prior to proposed dosing or delay vaccination until after Day 56.
• . Use of nonprescription systemic drugs within 7 days before study product administration (includes vitamins, antacids\*, over-the-counter drugs\*\*, herbal/dietary supplements, etc.) through Day 28\*\*\*
• . Hypertension, with confirmed systolic blood pressure (BP) greater than 140 mm Hg or confirmed diastolic BP greater than 90 mm Hg, measured after 5 minutes of rest at Screening.
• . Hypotension, with confirmed systolic BP less than 90 mm Hg.
• . Resting heart rate (HR) less than 45 bpm or greater than 100 bpm at Screening.
• . Body weight less than 50 kg.

Frequency of Clinically Significant Electrocardiogram (ECG) Results

Timeframe: Day 1 through Day 150