Study of AT-527 in Healthy Subjects (R07496998)

NCT04711187 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-03A-002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

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

  Day 10

Secondary Outcomes (2)

• Pharmacokinetics (PK) of AT-527

  Days 1 and 5

• Pharmacokinetics (PK) of AT-527

  Days 1 and 5

Study Arms (7)

AT-527 Formulation 1 Dose 1

EXPERIMENTAL

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

AT-527 Formulation 2 Dose 1

EXPERIMENTAL

Drug: AT-527 Formulation 2

AT-527 Formulation 2 Dose 2

EXPERIMENTAL

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

AT-527 Formulation 1 Dose 3

EXPERIMENTAL

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

AT-527 Formulation 2 Dose 3

EXPERIMENTAL

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

AT-527 Formulation 2 Dose 1 Fast/Fed

EXPERIMENTAL

Drug: AT-527 Formulation 2

AT-527 Formulation 2 Dose 3 Fast/Fed

EXPERIMENTAL

Drug: AT-527 Formulation 2

Interventions

AT-527 Formulation 1 DRUG

AT-527 Formulation 1 (R07496998)

AT-527 Formulation 1 Dose 1; AT-527 Formulation 1 Dose 3

Placebo Comparator OTHER

Placebo Comparator

AT-527 Formulation 1 Dose 1; AT-527 Formulation 1 Dose 3; AT-527 Formulation 2 Dose 2; AT-527 Formulation 2 Dose 3

AT-527 Formulation 2 DRUG

AT-527 Formulation 2 (R07496998)

AT-527 Formulation 2 Dose 1; AT-527 Formulation 2 Dose 1 Fast/Fed; AT-527 Formulation 2 Dose 2; AT-527 Formulation 2 Dose 3; AT-527 Formulation 2 Dose 3 Fast/Fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Atea Study Site

Montreal, Quebec, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: November 2, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: February 25, 2022

Record last verified: 2021-07

Locations

CA (1)