DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.
DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
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).
Sterile 9% saline for injection.
Monash Health
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Queen Mary Hospital (The University of Hong Kong)
Hong Kong, Hong Kong
Clinical Site
Auckland, New Zealand
Number of healthy volunteers with Adverse Events as assessed by CTCAE v5.0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Time frame: 4 weeks
Number participants with non-cirrhotic chronic Hepatitis B with Adverse Events as assessed by CTCAE v5.0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Time frame: 16 weeks
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring plasma pharmacokinetics profiles of DCR-S219
Measure the amount of DCR-HBVS excreted in urine
Time frame: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in healthy volunteers by monitoring through concentrations of DCR-S219
Measure the amount of DCR-HBVS renal clearance (CLR).
Time frame: 4 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring plasma pharmacokinetics profiles of DCR-HBVS.
Measure the amount of DCR-HBVS excreted in urine
Time frame: 12 weeks
To characterize the pharmacokinetics of DCR-HBVS in participants with non-cirrhotic CHB by monitoring through concentrations of DCR-HBVS.
Measure DCR-HBVS renal clearance (CLR).
Time frame: 12 weeks
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Middlemore Hospital
Auckland, New Zealand
Seoul National University Hospital
Seoul, South Korea
Seoul Metropolitan Government - Seoul National University Boramae Medical Center
Soeul, South Korea
King Culalongkorn Memorial Hospital
Bangkok, Thailand
Srinagarind Hospital
Khon Kaen, Thailand