Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

Study Overview

• Status: Withdrawn
• Conditions: Hepatitis C Virus Infection; Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; HCV Infection
• Intervention / Treatment: Drug: AT-777; Drug: Placebo; Drug: AT-527

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All:

• Body mass index (BMI) of 18-35 kg/m2
• Must agree to use protocol-specified methods of contraception
• Negative pregnancy test
• Willing to comply with the study requirements and to provide written informed consent

Additional for Part A:

-18-55 years of age

Additional for Part B:

• 18-65 years of age
• HCV genotype 1, 2 or 3
• Documented history compatible with chronic hepatitis C
• HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

All:

• Pregnant or breastfeeding
• Abuse of alcohol or drugs
• Use of other investigational drugs within 30 days of dosing
• Other clinically significant medical conditions

Additional for Part B:

• Prior exposure to any HCV NS5A inhibitor
• Cirrhosis
• Co-infection with hepatitis B virus or HIV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - 60 mg AT-777 single dose	Drug: AT-777; Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
Experimental: Part A - 120 mg AT-777 single dose	Drug: AT-777; Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
Placebo Comparator: Part A - Placebo single dose	Drug: Placebo; Administered orally, as one or two placebo capsules, depending on the arm.
Experimental: Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks	Drug: AT-777; Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.; Drug: AT-527; Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Number of subjects experiencing treatment-emergent adverse events	Through Day 6 for subjects in Part A
Incidence of Treatment-Emergent Adverse Events	Number of subjects experiencing treatment-emergent adverse events	Through 4 weeks after end of treatment for subjects in Part B
Antiviral Activity of AT-777 and AT-527	Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND)	Through 2 weeks of treatment for subjects in Part B

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AT-777 maximum plasma concentration (Cmax)	PK	Day 1 for subjects in Part A
AT-777 area under the concentration-time curve (AUC)	PK	Day 1 for subjects in Part A
Proportion of subjects achieving sustained virologic response (SVR)	SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment	12 weeks after end of treatment for subjects in Part B

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Investigators: Study Director: Xiao-Jian Zhou, Atea Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: AT-01C-001; 2019-004997-24 (EudraCT Number)

Drug and device information, study documents

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