Study of AT-527 in Healthy Subjects (R07496998)

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: AT-527 Formulation 1; Drug: AT-527 Formulation 2; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04711187

AT-03A-002

Details and patient eligibility

About

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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/m2
• Willing to comply with the study requirements and to provide written informed consent

Exclusion criteria

• Pregnant or breastfeeding
• Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
• Abuse of alcohol or drugs
• Use of other investigational drugs within 28 days of dosing
• Other clinically significant medical conditions or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 7 patient groups

AT-527 Formulation 1 Dose 1

Experimental group

Treatment:

Drug: AT-527 Formulation 1

Other: Placebo Comparator

AT-527 Formulation 2 Dose 1

Experimental group

Treatment:

Drug: AT-527 Formulation 2

AT-527 Formulation 2 Dose 2

Experimental group

Treatment:

Drug: AT-527 Formulation 2

Other: Placebo Comparator

AT-527 Formulation 1 Dose 3

Experimental group

Treatment:

Drug: AT-527 Formulation 1

Other: Placebo Comparator

AT-527 Formulation 2 Dose 3

Experimental group

Treatment:

Drug: AT-527 Formulation 2

Other: Placebo Comparator

AT-527 Formulation 2 Dose 1 Fast/Fed

Experimental group

Treatment:

Drug: AT-527 Formulation 2

AT-527 Formulation 2 Dose 3 Fast/Fed

Experimental group

Treatment:

Drug: AT-527 Formulation 2