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

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: GS-441524 (QD, 7 days) 		750 mg GS-441524 administered QD for 7 days
  • Drug: GS-441524
    750 mg administered as a solution
    Other names:
    • Parent nucleoside of remdesivir
Experimental
Part 2: GS-441524 (TID, 3 days) 		750 mg GS-441524 administered TID for 3 days
  • Drug: GS-441524
    750 mg administered as a solution
    Other names:
    • Parent nucleoside of remdesivir

Recruiting Locations

More Details

NCT ID
NCT04859244
Status
Completed
Sponsor
Copycat Sciences LLC

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.