This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Investigative Site
Beijing, Beijing Municipality, China
Investigative Site
Changchun, Jilin, China
Incidence of Treatment-emergent Adverse Events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Time frame: up to 48 weeks
Clinical Assessments Including But Not Limited to Laboratory Test Results
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs
Time frame: up to 48 weeks
PK: Maximum Plasma Concentration
VIR-2218 and metabolite maximum plasma concentrations (ng/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Time to Reach Maximum Plasma Concentration
VIR-2218 and metabolite time to Cmax (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint
VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng\*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
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Time frame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Area Under the Plasma Concentration Versus Time Curve to Infinity
VIR-2218 and metabolite area under the curve from time 0 to infinity (ng\*h/mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Percent of Area Extrapolated From AUC Last to Infinity
VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Terminal Elimination Half-life
VIR-2218 and metabolite apparent terminal elimination half-life (h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Plasma Clearance
VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).
PK: Apparent Volume of Distribution
VIR-2218 and metabolite apparent volume of distribution Vz/F (mL) VIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.
Time frame: Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).
Maximum Change of Serum HBsAg From Baseline
Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)
Time frame: up to 16 weeks
Number of Participants With Serum HBsAg Loss
Number of participants with serum HBsAg \< 0.05 IU/mL at two or more consecutive measurements
Time frame: up to 48 weeks
Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months
Number of participants with sustained serum HBsAg \< 0.05 IU/mL at all visits for at least 6 months
Time frame: up to 48 weeks
Number of Participants With Anti-HBs Seroconversion at Any Timepoint
Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements
Time frame: up to 48 weeks
For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
HBeAg loss is defined as quantitative HBeAg \< 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements.
Time frame: up to 48 weeks