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

Phase 1

Withdrawn

• Conditions: HCV Infection; Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection
• Interventions: Drug: AT-777; Drug: Placebo; Drug: AT-527

• Registration Number: NCT04309734
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-16
• Study Start: 2021-10
• Status Verified: 2022-06
• Primary Completion: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A - 60 mg AT-777 single dose	AT-777	-
Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks	AT-777	-
Part A - 120 mg AT-777 single dose	AT-777	-
Part A - Placebo single dose	Placebo	-
Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks	AT-527	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Site; 🇧🇪 Antwerp, Belgium