Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03772249 | Study of Safety and Tolerability of DCR HBVS | PHASE1 | COMPLETED | 82 | — | — | Dec 28, 2018 | Jul 12, 2022 | Sep 19, 2024 | 9 | Australia, Hong Kong +3 |
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
| Arm | Type | Description |
|---|---|---|
| Cohort A1 DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 0.1mg/kg of DCR-HBVS (HV) |
| Cohort A1 Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 0.1mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A2 DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 1.5mg/kg of DCR-HBVS (HV) |
| Cohort A2 Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A3 DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 3mg/kg of DCR-HBVS (HV) |
| Cohort A3 Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A4 DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 6mg/kg of DCR-HBVS (HV) |
| Cohort A4 Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort A5 DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 12mg/kg of DCR-HBVS (HV) |
| Cohort A5 Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 12mg/kg of Placebo for DCR-HBVS (HV) |
| Cohort B DCR-HBVS | EXPERIMENTAL | Single dose, Subcutaneous injection of 3mg/kg of for DCR-HBVS (NUC naïve, CHB) |
| Cohort B Placebo | PLACEBO_COMPARATOR | Single dose, Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS (NUC naïve, CHB) |
| Cohort C1 DCR-HBVS | EXPERIMENTAL | 4 doses- Subcutaneous injection of 1.5mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C1 Placebo | PLACEBO_COMPARATOR | 4 doses- Subcutaneous injection of 1.5mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C2 DCR-HBVS | EXPERIMENTAL | 4 doses- Subcutaneous injection of 3mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C2 Placebo | PLACEBO_COMPARATOR | 4 doses- Subcutaneous injection of 3mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C3 DCR-HBVS | EXPERIMENTAL | 4 doses- Subcutaneous injection of 6mg/kg of DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort C3 Placebo | PLACEBO_COMPARATOR | 4 doses- Subcutaneous injection of 6mg/kg of Placebo for DCR-HBVS administered every 28 days (NUC experienced, CHB) |
| Cohort 4C DCR-HBVS | EXPERIMENTAL | 1 dose- Subcutaneous injection of 100mg (NUC experienced, CHB) 1 dose- Subcutaneous injection of 200mg (NUC experienced, CHB) 1 dose- Subcutaneous injection of 400mg (NUC experienced, CHB) |
| Cohort 5C1 DCR-HBVS | EXPERIMENTAL | 4 doses- Subcutaneous injection of 200mg administered every 4 weeks (NUC experienced, CHB) |
| Cohort 5C2 DCR-HBVS | EXPERIMENTAL | 2 doses- Subcutaneous injection of 200mg administered every 8 weeks (NUC experienced, CHB) |
| Cohort 5C3 DCR-HBVS | EXPERIMENTAL | 2 doses- Subcutaneous injection of 400mg administered every 12 weeks (NUC experienced, CHB) |
| Name | Type | Description |
|---|---|---|
| DCR-HBVS | DRUG | DCR-HBVS is a synthetic ribonucleic acid interference (RNAi) drug that consists of a double-stranded oligonucleotide conjugated to N-acetyl-D-galactosamine (GalNAc) ligands. DCR-HBVS is a sterile solution of the siRNA (DCR-S219) at a concentration of 195 mg/mL in water for injection (WFI). |
| Placebo for DCR-HBVS | DRUG | Sterile 9% saline for injection. |
Inclusion Criteria: * Healthy at the time of screening as determined by medical evaluation. * Capable of giving informed consent. * 12-lead ECG within normal limits or with no clinically significant abnormalities. * Negative screen for alcohol or drugs of abuse. * Non-smokers for at least 3 months ...