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

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Copycat Sciences LLC
• Treatments: Remdesivir

Criteria

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