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Also known as Single Ascending Dose (SAD) Cohorts GS-9620
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)...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
GS-9620 is an investigational small molecule developed by Gilead Sciences, Inc. for infectious disease. It was studied in Phase 1 clinical trials in patients with chronic hepatitis B and chronic hepatitis C. The single ascending dose cohorts evaluated GS-9620 in controlled, randomized, double-blind studies.
GS-9620 was studied for the treatment of chronic hepatitis B and chronic hepatitis C. Phase 1 trials enrolled treatment naive hepatitis C patients, virologically suppressed chronic hepatitis B patients, and treatment naive chronic hepatitis B patients. It is an investigational agent and is not an approved therapy.
GS-9620 is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead sponsored the Phase 1 clinical program evaluating the compound in chronic hepatitis B and chronic hepatitis C.
GS-9620 is in Phase 1 development. All three listed trials are Phase 1 studies, and all have completed. The program enrolled approximately 100 participants across the single ascending dose cohorts. GS-9620 is investigational and has not been approved by the FDA.
GS-9620 was evaluated in Phase 1 trials including NCT01591668 in treatment naive chronic hepatitis C, NCT01590654 in virologically suppressed chronic hepatitis B, and NCT01590641 in treatment naive chronic hepatitis B. All three trials are completed and enrolled 51, 51, and 49 participants respectively.
Yes. GS-9620 is also referred to as Single Ascending Dose (SAD) Cohorts GS-9620. Both names describe the same Gilead Sciences compound studied in Phase 1 dose-escalation trials for chronic hepatitis B and chronic hepatitis C.