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

NCT06274853 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GS-441524

Oral GS-441524 capsules

DRUG

Placebo

Placebo capsules

Sponsors & Collaborators

  • Leidos Biomedical Research, Inc.

    collaborator INDUSTRY

  • ICON Government and Public Health Solutions, Inc

    collaborator UNKNOWN

  • National Center for Advancing Translational Sciences (NCATS)

    lead NIH

Principal Investigators

  • Philip E Sanderson, PhD · NCATS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274853 on ClinicalTrials.gov