Phase 2 N=82 Randomized Quadruple-blind Treatment

Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

Chronic Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT03672188 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Dec 2021

Primary outcome: Primary: Incidence of Adverse Events (AEs) — 4; 3; 4; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VIR-2218 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vir Biotechnology, Inc.
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs)	4; 3; 4; 5; 3; 3	—
PRIMARY Clinical Assessments Including But Not Limited to Laboratory Test Results	1; 1; 1; 1; 1; 0	—
SECONDARY Maximum Plasma Concentration (ng/mL)	155; 355; 711; 2110; 1830; 5010	—
SECONDARY Time to Reach Maximum Plasma Concentration (h)	4.25; 4.32; 5.21; 7.21; 7.21; 4.25	—
SECONDARY Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)	1270; 3740; 6630; 23500; 27900; 58800	—
SECONDARY Apparent Terminal Elimination Half-life (h)	2.45; 3.64; 4.38; 3.54; 5.28; 4.55	—
SECONDARY Apparent Plasma Clearance (L/h)	34.0; 21.8; 30.8; 16.8; 21.9; 15.3	—
SECONDARY Apparent Volume of Distribution (L)	155; 132; 223; 104; 176; 92.9	—
SECONDARY Urine %fe 0-24h	16.9; 21.7; 23.2; 29.5; 32.3; 47.6	—
SECONDARY Apparent Renal Clearance (CLR/F)	5.87; 5.22; 7.00; 5.13; 7.22; 7.47	—
SECONDARY Maximum Reduction of Serum HBsAg From Baseline	-1.031; -1.230; -1.504; -1.653; -1.161; -1.568	—
SECONDARY Number of Subjects With Serum HBsAg Loss at Any Time Point	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Anti-HBs Seroconversion at Any Timepoint	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint	0; 1; 0; 0; 1; 0	—

Summary

This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV). In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B & Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.

Eligibility Criteria

Part A SAD:

Inclusion Criteria

Male or female age 18 - 55
BMI 18 - 32 kg/m^2

Exclusion Criteria

Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
History or evidence of drug or alcohol abuse
History of intolerance to SC injection

Parts B/C MAD:

Inclusion Criteria

Male or female age 18 - 65
BMI 18 - 32 kg/m^2
Chronic HBV infection 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03672188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.