Trial | NCT03219957  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    AT-527 ...

  • Study Participants

    88
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 Started
Jul 06
2017
Primary Completion
Jun 20
2018
Study Completion
Jun 20
2018
Last Update
Feb 18
2020

Drug AT-527

Ascending doses of AT-527 administered orally.

Other Placebo Comparator

Matching placebo

AT-527 Experimental

Placebo Placebo Comparator

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

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
No Results Posted