This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
49
Oral dosing with placebo capsules to match RO7020322.
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
Queen Mary Hospital
Hong Kong, Hong Kong
Auckland Clinical Studies Limited
Grafton, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Number of participants with adverse events
Time frame: Up to 8 weeks
Intensity of adverse events
Time frame: Up to 8 weeks
Number of participants with clinically significant laboratory abnormalities
Time frame: Up to 8 weeks
Number of participants with clinically significant electrocardiogram (ECG) abnormalities
Time frame: Up to 8 weeks
Number of participants with clinically significant vital signs abnormalities
Time frame: Up to 8 weeks
Maximum observed plasma concentration (Cmax) of RO7020322
Time frame: Up to 18 days
Time from dosing to Cmax (Tmax) of RO7020322
Time frame: Up to 18 days
Trough plasma concentrations (Ctrough) of RO7020322
Time frame: Up to 18 days
Area under the plasma concentration-time curve between time zero (pre-dose) and the time of the last quantifiable concentration (AUClast) of RO7020322
Time frame: Up to 18 days
Area under the plasma concentration-time curve between time zero (pre-dose) extrapolated to infinity (AUC0-Inf) of RO7020322
Time frame: Up to 18 days
Apparent clearance (CL/F) of RO7020322
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Time frame: Up to 18 days
Apparent volume (V/F) of RO7020322
Time frame: Up to 18 days
Apparent terminal phase half-life (t1/2) of RO7020322
Time frame: Up to 18 days
Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state
Time frame: Up to 18 days
Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1
Time frame: Up to 18 days
Plasma concentration of hepatitis B surface antigen (HBsAg)
Time frame: Up to 8 weeks