Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

Phase 2

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: VIR-2218; Drug: Placebo

• Registration Number: NCT04507269
• Lead Sponsor: Brii Biosciences Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-08-18
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Disposition First Submitted: 2022-07-26
• Results First Submitted: 2024-07-02
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Results First Posted: 2024-08-26
• Disposition First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Male or female age 18 - 65;
• Weight ≥ 40 kg to ≤ 125 kg;
• Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;

Exclusion Criteria

• Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
• Significant fibrosis or cirrhosis;
• History or evidence of drug or alcohol abuse;
• History of intolerance to SC injection;
• History of chronic liver disease from any cause other than chronic HBV infection;
• History of hepatic decompensation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIR-2218	VIR-2218	Drug: VIR-2218 VIR-2218 given by subcutaneous injection
Placebo	Placebo	Drug: Placebo Saline given by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events (TEAEs)	up to 48 weeks	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.
Clinical Assessments Including But Not Limited to Laboratory Test Results	up to 48 weeks	Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Plasma Concentration	Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
PK: Time to Reach Maximum Plasma Concentration	Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
Number of Participants With Serum HBsAg Loss	up to 48 weeks	Number of participants with serum HBsAg \< 0.05 IU/mL at two or more consecutive measurements
Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months	up to 48 weeks	Number of participants with sustained serum HBsAg \< 0.05 IU/mL at all visits for at least 6 months
Number of Participants With Anti-HBs Seroconversion at Any Timepoint	up to 48 weeks	Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements
PK: Percent of Area Extrapolated From AUC Last to Infinity	Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
PK: Apparent Terminal Elimination Half-life	Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint	Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
PK: Area Under the Plasma Concentration Versus Time Curve to Infinity	Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
PK: Apparent Volume of Distribution	Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.
Maximum Change of Serum HBsAg From Baseline	up to 16 weeks	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)
For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint	up to 48 weeks	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.
PK: Apparent Plasma Clearance	Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).	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.

Trial Locations

Locations (1)

Investigative Site; 🇨🇳 Changchun, Jilin, China