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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004997-24 | EudraCT Number |
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Withdrawn prior to study initiation.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - 60 mg AT-777 single dose | Experimental |
| |
| Part A - 120 mg AT-777 single dose | Experimental |
| |
| Part A - Placebo single dose | Placebo Comparator |
| |
| Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AT-777 maximum plasma concentration (Cmax) | PK | Day 1 for subjects in Part A |
| AT-777 area under the concentration-time curve (AUC) | PK |
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Inclusion Criteria:
All:
Additional for Part A:
-18-55 years of age
Additional for Part B:
Exclusion Criteria:
All:
Additional for Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jian Zhou | Atea Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000713067 | AT-511 |
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Part A is randomized, double-blind. Part B is open label.
| Placebo | Drug | Administered orally, as one or two placebo capsules, depending on the arm. |
|
| 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. |
|
| Day 1 for subjects in Part A |
| Proportion of subjects achieving sustained virologic response (SVR) | SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment | 12 weeks after end of treatment for subjects in Part B |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |