Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCR-HBVS · 1 trial · 1 indication
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 ...
DCR-HBVS is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety and tolerability in patients with this condition.
DCR-HBVS is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with chronic Hepatitis B.
DCR-HBVS is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and tolerability in healthy volunteers and patients with chronic Hepatitis B.
DCR-HBVS has one completed Phase 1 clinical trial registered under NCT03772249, titled 'Study of Safety and Tolerability of DCR HBVS'. This trial enrolled 82 participants and was conducted in Australia, Hong Kong, New Zealand, South Korea, and Thailand.
Yes, DCR-HBVS is also referred to as DCR HBVS in clinical trial documentation. The trial NCT03772249 uses the title 'Study of Safety and Tolerability of DCR HBVS', confirming that these names refer to the same investigational drug.