A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects

Atea Pharmaceuticals, Inc.1 site in 1 country88 target enrollmentJuly 6, 2017

ConditionsChronic Hepatitis C Hepatitis C Hepatitis C, Chronic

InterventionsAT-527 Placebo Comparator

DrugsAT-527

Overview

Phase: Phase 1
Intervention: AT-527
Conditions: Chronic Hepatitis C
Sponsor: Atea Pharmaceuticals, Inc.
Enrollment: 88
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.

Registry

clinicaltrials.gov

Start Date

July 6, 2017

End Date

June 20, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Atea Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects (healthy and HCV-infected subjects):
•Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
•Must have a negative pregnancy test at Screening and prior to dosing
•Minimum body weight of 50 kg
•Willing to comply with the study requirements and to provide written informed consent
•Additional inclusion criteria for HCV-infected subjects:
•Must have not received prior treatment for HCV infection
•Documented clinical history compatible with chronic HCV infection
•Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.

Exclusion Criteria

•All subjects (healthy and HCV-infected subjects):
•Pregnant or breastfeeding
•Infected with hepatitis B virus or HIV
•Abuse of alcohol or drugs
•Use of other investigational drugs within 28 days of dosing
•Other clinically significant medical conditions or laboratory abnormalities

Arms & Interventions

AT-527

Intervention: AT-527

Placebo

Intervention: Placebo Comparator

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time Frame: Through Day 35 for subjects receiving multiple doses.

Number of subjects experiencing treatment-emergent adverse events

Secondary Outcomes

Antiviral Activity of AT-527(Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.)
Pharmacokinetics (PK) of AT-527(Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses)