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Single Ascending Dose Cohorts GS-9620 · 3 trials · 3 indications
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
| Arm | Type | Description |
|---|---|---|
| 0.3mg GS-9620 | EXPERIMENTAL | - |
| 1mg GS-9620 | EXPERIMENTAL | - |
| 2mg GS-9620 | EXPERIMENTAL | - |
| 4mg GS-9620 | EXPERIMENTAL | - |
| 0.3mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 1mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 2mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| 4mg GS-9620 QW x 2 doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620. |
| Multiple Ascending Dose (MAD) Cohorts | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses) |
| Multiple Ascending Dose (MAD) Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses). |
| Single Ascending Dose Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620. |
| Multiple Ascending Dose Cohorts GS-9620 | DRUG | This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses). |
Inclusion Criteria: * Chronic HBV infection ≥ 6 months * HBsAg ≥ 250 IU/mL * HBV treatment naïve * Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis * Creatinine clearance ≥ 70 mL/min Exclusion Criteria: * Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV)...
GS-9620 is an investigational small molecule being studied for the treatment of chronic Hepatitis B and Hepatitis C. It is being developed by Gilead Sciences, Inc. (GILD) and is currently in Phase 1 clinical development.
GS-9620 is a small molecule being evaluated in clinical trials for chronic Hepatitis B and Hepatitis C. Its specific molecular target has not been disclosed in the available trial information.
GS-9620 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 1 clinical trials for Hepatitis B and Hepatitis C.
GS-9620 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for the treatment of chronic Hepatitis B and Hepatitis C.
GS-9620 has been studied in three completed Phase 1 clinical trials. These include NCT01590641 in treatment-naive subjects with chronic Hepatitis B, NCT01590654 in virologically suppressed subjects with chronic Hepatitis B, and NCT01591668 in treatment-naive subjects with chronic Hepatitis C.
GS-9620 is the drug name used in clinical trials. No alternative names for this drug have been disclosed in the available information. It is being developed by Gilead Sciences, Inc. for Hepatitis B and Hepatitis C.