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AT-527 Formulation 1

Phase 1

Healthy Volunteer Study | Small molecule | Other |Atea Pharmaceuticals, Inc.|Last Updated: Feb 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

AT-527 Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT04711187Study of AT-527 in Healthy Subjects (R07496998)Healthy Volunteer Study
COMPLETED81 Analytics
PHASE1COMPLETED
Study of AT-527 in Healthy Subjects (R07496998)
Healthy Volunteer StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
Day 10

Secondary Endpoints

Pharmacokinetics (PK) of AT-527
Days 1 and 5
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AT-527 Formulation 1 Dose 1EXPERIMENTAL -
AT-527 Formulation 2 Dose 1EXPERIMENTAL -
AT-527 Formulation 2 Dose 2EXPERIMENTAL -
AT-527 Formulation 1 Dose 3EXPERIMENTAL -
AT-527 Formulation 2 Dose 3EXPERIMENTAL -
AT-527 Formulation 2 Dose 1 Fast/FedEXPERIMENTAL -
AT-527 Formulation 2 Dose 3 Fast/FedEXPERIMENTAL -

Interventions

NameTypeDescription
AT-527 Formulation 1DRUGAT-527 Formulation 1 (R07496998)
Placebo ComparatorOTHERPlacebo Comparator
AT-527 Formulation 2DRUGAT-527 Formulation 2 (R07496998)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug * Females must have a negative pregnancy test at Screening and prior to dosing * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg...

Countries:Canada
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Frequently asked questions about AT-527 Formulation 1

What is AT-527 Formulation 1 used for?

AT-527 Formulation 1 is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial that enrolled 81 participants in Canada. The study was randomized, double-blind, and controlled, evaluating the drug in healthy subjects aged 18 years and older.

Who makes AT-527 Formulation 1?

AT-527 Formulation 1 is being developed by Atea Pharmaceuticals, Inc., which trades under the ticker AVIR. The company is conducting clinical research on this small molecule, with the current Phase 1 study completed. The trial was conducted in Canada with 81 healthy volunteers.

What phase is AT-527 Formulation 1 in?

AT-527 Formulation 1 is in Phase 1 clinical development. The single trial, NCT04711187, has been completed. This Phase 1 study was a randomized, double-blind, controlled trial involving 81 healthy volunteers in Canada. The drug is investigational and not yet approved for any use.

What clinical trials is AT-527 Formulation 1 in?

AT-527 Formulation 1 has one completed Phase 1 clinical trial, identified as NCT04711187, titled 'Study of AT-527 in Healthy Subjects (R07496998)'. This trial enrolled 81 healthy volunteers in Canada, with participants aged 18 years and older. The study was randomized, double-blind, and controlled.

Is AT-527 Formulation 1 FDA approved?

AT-527 Formulation 1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only trial, NCT04711187, has been completed and involved healthy volunteers. The drug has not yet progressed to later-stage trials or received regulatory approval.