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This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRV431 | Experimental | Either single or multiple doses of varying dose levels |
|
| Placebo | Placebo Comparator |
| |
| TDF | Experimental | 300 mg TDF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRV431 | Drug | Single or multiple dose(s) of CRV431 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for HBV Pilot Subjects Only:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Greytok | ContraVir Pharmaceutical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Tempe | Arizona | 85283 | United States | ||
| Celerion, Inc |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D003141 | Communicable Diseases |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| C000654430 | CRV-431 |
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| Drug |
Single Placebo dose |
|
| TDF | Drug | Single or multiple dose(s) of TDF |
|
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| D014777 |
| Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |