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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects

Conditions
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Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic

Intervention / Treatment
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* Drug: AT-527
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527<br> | Drug: AT-527<br>* Ascending doses of AT-527 administered orally.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo Comparator<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of subjects experiencing treatment-emergent adverse events | Through Day 6 for subjects receiving a single dose | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of subjects experiencing treatment-emergent adverse events | Through Day 35 for subjects receiving multiple doses. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 | Maximum plasma concentration (Cmax) | Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses | 
| Pharmacokinetics (PK) of AT-527 | Area under the concentration-time curve (AUC) | Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses | 
| Antiviral Activity of AT-527 | Change from baseline in plasma HCV RNA | Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections