First-in-Human Study of Orally Administered GS-441524 for COVID-19

First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer

This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.

Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.

Inclusion Criteria:

• Willing and able to provide written informed consent
• Negative pregnancy test at screening and prior to dosing
• Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

• Use of other investigational drugs within 28 days of dosing
• Positive pregnancy test
• Abuse of alcohol or drugs
• Other clinically significant medical conditions or laboratory abnormalities