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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C
• Intervention / Treatment: Drug: AT-527; Other: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Clinical Trial Site
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo Comparator; Matching placebo
EXPERIMENTAL: AT-527	Drug: AT-527; Ascending doses of AT-527 administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of subjects experiencing treatment-emergent adverse events	Through Day 6 for subjects receiving a single dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of subjects experiencing treatment-emergent adverse events	Through Day 35 for subjects receiving multiple doses.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 30;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2017
• Primary Completion (ACTUAL): June 20, 2018
• Study Completion (ACTUAL): June 20, 2018

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: HCV; Hepatitis C Virus; Liver Diseases; Flaviviridae Infections; Flavivirus; Hepatitis, Viral, Human; RNA Viruses
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: AT-01B-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No