protocolSection identificationModule nctId: NCT06274853, orgStudyIdInfo id: 170327-0001, secondaryIdInfos id: 6830/0003, type: OTHER, domain: ICON plc, briefTitle: GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Center for Advancing Translational Sciences (NCATS), class: NIH, collaborators name: Leidos Biomedical Research, Inc., collaborators name: ICON Government and Public Health Solutions, Inc, descriptionModule briefSummary: 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., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: GS-441524, interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Blood Pressure in mm/Hg, primaryOutcomes measure: Pulse in beats/min, primaryOutcomes measure: Respiratory Rate in breaths per minute, primaryOutcomes measure: Body Temperature in degrees, primaryOutcomes measure: Electrocardiogram (ECG) as measured by PR interval, primaryOutcomes measure: Electrocardiogram (ECG) as measured by QT interval, primaryOutcomes measure: Electrocardiogram (ECG) as measured by QT corrected (Fridericia's), secondaryOutcomes measure: Plasma PK Parameter C-Max, secondaryOutcomes measure: Plasma PK Parameter t-max, secondaryOutcomes measure: Plasma PK Parameter t-lag, secondaryOutcomes measure: Plasma PK Parameter AUC 0-last, secondaryOutcomes measure: Plasma PK Parameter AUC 0-inf, secondaryOutcomes measure: Plasma PK Parameter t 1/2, secondaryOutcomes measure: Plasma PK Parameter CL/F, secondaryOutcomes measure: Plasma PK Parameter Vz/F, secondaryOutcomes measure: Urine PK Parameter Ae urine, secondaryOutcomes measure: Urine PK Parameter Fe urine, secondaryOutcomes measure: Urine PK Parameter CL R, secondaryOutcomes measure: Plasma PK Parameter C trough, secondaryOutcomes measure: Plasma PK Parameter AUC 0-tau, secondaryOutcomes measure: Plasma PK Parameter CL/F ss, secondaryOutcomes measure: Plasma PK Parameter Vz/F ss, secondaryOutcomes measure: Plasma PK Parameter R ac, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False