Study of AT-527 in Healthy and HCV-Infected Subjects

Phase 1

Completed

• Conditions: Chronic Hepatitis C; Hepatitis C; Hepatitis C, Chronic
• Interventions: Other: Placebo Comparator; Drug: AT-527

• Registration Number: NCT03219957
• Lead Sponsor: Atea Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	-
AT-527	AT-527	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Through Day 35 for subjects receiving multiple doses.	Number of subjects experiencing treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Antiviral Activity of AT-527	Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.	Change from baseline in plasma HCV RNA
Pharmacokinetics (PK) of AT-527	Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses	Area under the concentration-time curve (AUC)

Trial Locations

Locations (1)

Clinical Trial Site; 🇲🇩 Chisinau, Moldova, Republic of