Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
Conditions
Keywords
HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections
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.
Interventions
DRUGAT-527
Ascending doses of AT-527 administered orally.
OTHERPlacebo Comparator
Matching placebo
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through Day 6 for subjects receiving a single dose | Number of subjects experiencing treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of AT-527 | Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses | Maximum plasma concentration (Cmax) |
| Antiviral Activity of AT-527 | Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses. | Change from baseline in plasma HCV RNA |
Countries
Belgium, Moldova
Outcome results
None listed