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

NCT04309734 | Withdrawn Phase 1

• 2 other identifiers: AT-01C-0012019-004997-24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• AT-777 maximum plasma concentration (Cmax)

  Day 1 for subjects in Part A

• AT-777 area under the concentration-time curve (AUC)

  Day 1 for subjects in Part A

• Proportion of subjects achieving sustained virologic response (SVR)

  12 weeks after end of treatment for subjects in Part B

Study Arms (4)

Part A - 60 mg AT-777 single dose

EXPERIMENTAL

Drug: AT-777

Part A - 120 mg AT-777 single dose

EXPERIMENTAL

Drug: AT-777

Part A - Placebo single dose

PLACEBO COMPARATOR

Drug: Placebo

Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

EXPERIMENTAL

Drug: AT-777; Drug: AT-527

Interventions

AT-777 DRUG

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

Part A - 120 mg AT-777 single dose; Part A - 60 mg AT-777 single dose; Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

Placebo DRUG

Administered orally, as one or two placebo capsules, depending on the arm.

Part A - Placebo single dose

AT-527 DRUG

Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• years of age
• Additional for Part B:
• years of age
• HCV genotype 1, 2 or 3
• Documented history compatible with chronic hepatitis C
• HCV RNA ≥ 10,000 IU/mL at Screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Antwerp, Belgium

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

AT-511

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiao-Jian Zhou

  Atea Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Part A is randomized, double-blind. Part B is open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 16, 2020
• Study Start: October 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

BE (1)