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NCT06274853Not yet recruiting

GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects

A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-441524 in Healthy Subjects
National Center for Advancing Translational Sciences (NCATS)Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
COVID-19
Drug/Device/Intervention
GS-441524
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
National Center for Advancing Translational Sciences (NCATS)
Funder
National Institute of Allergy and Infectious Diseases (NIAID)
Timeline & enrollment
Phase
Phase 1
Start date
Mar 15, 2024
End date
Dec 01, 2024
Enrollment
70 participants
Primary outcome

Treatment-emergent adverse events (TEAEs),Blood Pressure in mm/Hg,Pulse in beats/min,Respiratory Rate in breaths per minute,Body Temperature in degrees,Electrocardiogram (ECG) as measured by PR interval,Electrocardiogram (ECG) as measured by QT interval,Electrocardiogram (ECG) as measured by QT corrected (Fridericia's)

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics
 of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of
 GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state
 produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.
 
 Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma
 levels.

ICD-10 classifications
COVID-19, virus identifiedCOVID-19, virus not identifiedCoronavirus infection, unspecified siteViral infection, unspecifiedRift Valley fever
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06274853
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06274853 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Center for Advancing Translational Sciences (NCATS) and is currently Not yet recruiting. The study focuses on COVID-19. Target enrollment is 70 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.