Status:
COMPLETED
First-in-Human Study of Orally Administered GS-441524 for COVID-19
Lead Sponsor:
Copycat Sciences LLC
Conditions:
COVID-19
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04859244
Start Date
January 1 2021
End Date
August 1 2021
Last Update
August 10 2021
Active Locations (1)
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1
Copycat Sciences Study Site
Houston, Texas, United States, 77054