Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: AT-527 single dose; Drug: AT-527; Drug: AT-527 fasted; Other: Placebo Comparator fed; Drug: AT-527 fed; Other: Placebo Comparator fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT05256732

AT-03A-015

Details and patient eligibility

About

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects

Enrollment: 136 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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136 participants in 4 patient groups, including a placebo group

AT-527

Experimental group

Treatment:

Drug: AT-527 fed

Drug: AT-527 fasted

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator fasted

Other: Placebo Comparator fed

AT-527 BID

Experimental group

Treatment:

Drug: AT-527

AT-527 single dose fasted/fed

Experimental group

Treatment:

Drug: AT-527 single dose