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

NCT ID: NCT03219957

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-06
• Study Completion Date: 2018-06-20

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.

Conditions

Chronic Hepatitis C; Hepatitis C; Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AT-527

Group Type: EXPERIMENTAL

AT-527

Intervention Type: DRUG

Ascending doses of AT-527 administered orally.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: OTHER

Matching placebo

Interventions

AT-527

Ascending doses of AT-527 administered orally.

Intervention Type: DRUG

Placebo Comparator

Matching placebo

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao-Jian Zhou, PhD

Role: STUDY_DIRECTOR

Atea Pharmaceuticals, Inc.

Locations

Clinical Trial Site

Antwerp, , Belgium

Clinical Trial Site

Chisinau, , Moldova

Countries

Belgium; Moldova

References

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 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30.

Reference Type: RESULT

PMID: 31570394 (View on PubMed)

Other Identifiers

AT-01B-001

Identifier Type: -

Identifier Source: org_study_id