NCT04507269 is a Phase 2 clinical trial of VIR-2218 in Hepatitis B, Chronic, sponsored by Brii Biosciences Limited.

Who is sponsoring NCT04507269?

NCT04507269 is sponsored by Brii Biosciences Limited.

What drugs are being tested in NCT04507269?

Interventions in NCT04507269: VIR-2218, Placebo.

What condition does NCT04507269 study?

NCT04507269 studies Hepatitis B, Chronic.

Is NCT04507269 still recruiting?

NCT04507269 is currently completed. Last updated 26 August 2024.

Are results published for NCT04507269?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-26 · How we verify

NCT04507269

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 26 August 2024

What this trial tests

Phase 2 trial testing VIR-2218 in Hepatitis B, Chronic in 21 participants. Completed in 30 September 2021.

Timeline

18 August 2020

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Brii Biosciences Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	18 August 2020
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	2 locations across China

Drugs / interventions tested

VIR-2218 — full drug profile →
Placebo

Conditions studied

Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

Brii Biosciences Limited — full company profile →

Who can join

Adults 18 to 65, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment-emergent Adverse Events (TEAEs) Primary · 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.

Any TEAEs

Group	Value	95% CI
Part 1: VIR-2218 50 mg	1
Part 1: VIR-2218 100 mg	2
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	2
Part 2: VIR-2218 100 mg	1
Part 2: Placebo	1

Any TEAEs of CTCAE Grade 1

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	1
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	2
Part 2: VIR-2218 100 mg	1
Part 2: Placebo	1

Any TEAEs of CTCAE Grade 2

Group	Value	95% CI
Part 1: VIR-2218 50 mg	1
Part 1: VIR-2218 100 mg	1
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Any TEAEs of CTCAE Grade 3 or above

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Any drug related TEAEs

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	1
Part 2: VIR-2218 100 mg	1
Part 2: Placebo	0

Any serious TEAEs

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Clinical Assessments Including But Not Limited to Laboratory Test Results Primary · up to 48 weeks

Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs

Any post baseline laboratory abnormalities of CTCAE Grade 1

Group	Value	95% CI
Part 1: VIR-2218 50 mg	4
Part 1: VIR-2218 100 mg	4
Part 1: Placebo	2
Part 2: VIR-2218 50 mg	2
Part 2: VIR-2218 100 mg	4
Part 2: Placebo	2

Any post baseline laboratory abnormalities of CTCAE Grade 2 or above

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Any clinically significant vital signs

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Any clinically significant ECGs

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

PK: Maximum Plasma Concentration Secondary · 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.

VIR-2218 Cmax (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	120	± 40.5
Part 1: VIR-2218 100 mg	144	± 100.5
Part 2: VIR-2218 50 mg	65.8	± 58.6
Part 2: VIR-2218 100 mg	260	± 90.4

VIR-2218 Cmax (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	125	± 48.8
Part 1: VIR-2218 100 mg	198	± 52.9
Part 2: VIR-2218 50 mg	76.5	± 35.7
Part 2: VIR-2218 100 mg	268	± 43.0

AS(N-1)3'VIR-2218 Cmax (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	10.2	± NA
Part 1: VIR-2218 100 mg	31.4	± NA
Part 2: VIR-2218 100 mg	28.1	± 171.1

AS(N-1)3'VIR-2218 Cmax (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	16.3	± NA
Part 1: VIR-2218 100 mg	23.6	± 48.8
Part 2: VIR-2218 50 mg	9.75	± 1.1
Part 2: VIR-2218 100 mg	19.3	± 82.1

PK: Time to Reach Maximum Plasma Concentration Secondary · 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.

VIR-2218 Tmax (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	4.99	1.88 – 8.03
Part 1: VIR-2218 100 mg	2.00	0.967 – 8.08
Part 2: VIR-2218 50 mg	4.02	4.00 – 7.80
Part 2: VIR-2218 100 mg	4.00	4.00 – 7.58

VIR-2218 Tmax (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	7.76	1.08 – 8.13
Part 1: VIR-2218 100 mg	4.02	2.00 – 7.85
Part 2: VIR-2218 50 mg	2.50	0.967 – 4.00
Part 2: VIR-2218 100 mg	5.93	1.00 – 8.02

AS(N-1)3'VIR-2218 Tmax (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	7.95	3.98 – 8.05
Part 1: VIR-2218 100 mg	4.98	2.03 – 7.92
Part 2: VIR-2218 50 mg	7.80	7.80 – 7.80
Part 2: VIR-2218 100 mg	5.79	4.00 – 22.1

AS(N-1)3'VIR-2218 Tmax (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	7.76	4.05 – 8.13
Part 1: VIR-2218 100 mg	5.93	2.00 – 8.03
Part 2: VIR-2218 50 mg	4.00	4.00 – 4.00
Part 2: VIR-2218 100 mg	5.93	4.00 – 8.02

PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint Secondary · 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.

VIR-2218 AUClast (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	1080	± 25.3
Part 1: VIR-2218 100 mg	1400	± 115.6
Part 2: VIR-2218 50 mg	626	± 31.1
Part 2: VIR-2218 100 mg	3190	± 42.3

VIR-2218 AUClast (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	854	± 34.2
Part 1: VIR-2218 100 mg	2390	± 26.6
Part 2: VIR-2218 50 mg	580	± 56.9
Part 2: VIR-2218 100 mg	3140	± 15.8

AS(N-1)3'VIR-2218 AUClast (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	58.7	± 28.9
Part 1: VIR-2218 100 mg	159	± 30.5
Part 2: VIR-2218 50 mg	67.6	± 2.1
Part 2: VIR-2218 100 mg	180	± 63.4

AS(N-1)3'VIR-2218 AUClast (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	50.2	± 52.5
Part 1: VIR-2218 100 mg	140	± 81.2
Part 2: VIR-2218 50 mg	63.1	± 6.1
Part 2: VIR-2218 100 mg	155	± 39.8

PK: Area Under the Plasma Concentration Versus Time Curve to Infinity Secondary · 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.

VIR-2218 AUCinf (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	2820	± 16.7

VIR-2218 AUCinf (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	2570	± NA
Part 2: VIR-2218 50 mg	1210	± NA
Part 2: VIR-2218 100 mg	3530	± NA

PK: Percent of Area Extrapolated From AUC Last to Infinity Secondary · 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.

VIR-2218 %AUCextrap (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	2.69	± 5.1

VIR-2218 %AUCextrap (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	46.2	± NA
Part 1: VIR-2218 100 mg	13.8	± NA
Part 2: VIR-2218 50 mg	23.9	± 263.4
Part 2: VIR-2218 100 mg	5.88	± NA

AS(N-1)3'VIR-2218 %AUCextrap (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	49.2	± NA

PK: Apparent Terminal Elimination Half-life Secondary · 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.

VIR-2218 t1/2 (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	4.16	4.10 – 4.22

VIR-2218 t1/2 (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	7.66	7.66 – 7.66
Part 2: VIR-2218 50 mg	6.53	6.53 – 6.53
Part 2: VIR-2218 100 mg	5.49	5.49 – 5.49

PK: Apparent Plasma Clearance Secondary · 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.

VIR-2218 CL/F (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	35400	± 16.7

VIR-2218 CL/F (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	39000	± NA
Part 2: VIR-2218 50 mg	41300	± NA
Part 2: VIR-2218 100 mg	28300	± NA

PK: Apparent Volume of Distribution Secondary · 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.

VIR-2218 Vz/F (Day 1)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	213000	± 18.6

VIR-2218 Vz/F (Day 29)

Group	Value	95% CI
Part 1: VIR-2218 100 mg	431000	± NA
Part 2: VIR-2218 50 mg	389000	± NA
Part 2: VIR-2218 100 mg	224000	± NA

Maximum Change of Serum HBsAg From Baseline Secondary · 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)

Group	Value	95% CI
Part 1: VIR-2218 50 mg	-1.064	± 0.1047
Part 1: VIR-2218 100 mg	-1.346	± 0.5169
Part 1: Placebo	-0.049	± 0.0158
Part 2: VIR-2218 50 mg	-0.793	± 0.1017
Part 2: VIR-2218 100 mg	-1.268	± 0.1693
Part 2: Placebo	-0.120	± 0.0826

Number of Participants With Serum HBsAg Loss Secondary · up to 48 weeks

Number of participants with serum HBsAg \< 0.05 IU/mL at two or more consecutive measurements

Group	Value	95% CI
Part 1: VIR-2218 50 mg	0
Part 1: VIR-2218 100 mg	0
Part 1: Placebo	0
Part 2: VIR-2218 50 mg	0
Part 2: VIR-2218 100 mg	0
Part 2: Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 48 weeks after the first dose of VIR-2218 or placebo. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: VIR-2218 50 mg

Serious: 0/4 (0%)

Deaths: 0/4

Part 1: VIR-2218 100 mg 100 mg

Serious: 0/4 (0%)

Deaths: 0/4

Part 1: Placebo

Serious: 0/3 (0%)

Deaths: 0/3

Part 2: VIR-2218 50 mg

Serious: 0/4 (0%)

Deaths: 0/4

Part 2: VIR-2218 100 mg

Serious: 0/4 (0%)

Deaths: 0/4

Part 2: Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (10 terms — click to expand)

Reaction	System	Part 1: VIR-2218 50 mg	Part 1: VIR-2218 100 mg 10…	Part 1: Placebo	Part 2: VIR-2218 50 mg	Part 2: VIR-2218 100 mg	Part 2: Placebo
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Epigastric discomfort	Gastrointestinal disorders	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04507269 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
Toward a complete cure for chronic hepatitis B: Novel therapeutic targets for hepatitis B virus.
Kim SW, Yoon JS, Lee M, Cho Y. · · 2022 · cited 53× · PMID 34281294 · DOI 10.3350/cmh.2021.0093
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f
Recent Update on siRNA Therapeutics.
Ebenezer O, Oyebamiji AK, Olanlokun JO, Tuszynski JA, et al · · 2025 · cited 19× · PMID 40331977 · DOI 10.3390/ijms26083456
Current trends and advances in antiviral therapy for chronic hepatitis B.
Li J, Liu S, Zang Q, Yang R, et al · · 2024 · cited 7× · PMID 38945693 · DOI 10.1097/cm9.0000000000003178
Genomic medicine in hepatology: mechanisms and liver treatment strategies.
Kozlov DS, Rodimova S, Filatov P, Mozherov A, et al · · 2025 · cited 1× · PMID 41023586 · DOI 10.1186/s10020-025-01358-4
[Clinical research advances for small-molecule nucleic acid drugs in the treatment of chronic hepatitis B].
Wang WX, Guo YM, Fei ZX, Zhu SS, et al · · 2025 · PMID 41461559 · DOI 10.3760/cma.j.cn501113-20250114-00026

Verify or expand the search:

Other trials of VIR-2218

Trials testing the same drug.

NCT06070051 — Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nu · Phase 1 · active not recruiting
NCT05844228 — A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218 · Phase 1 · completed
NCT05612581 — A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection · Phase 1, PHASE2 · completed
NCT05484206 — Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 · Phase 1 · recruiting
NCT04891770 — Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of · Phase 2 · completed

Other recruiting trials for Hepatitis B, Chronic

Currently open trials in the same condition.

NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting

Other Brii Biosciences Limited trials

Trials by the same sponsor.

NCT06057012 — A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) · Phase 2 · completed
NCT05845840 — A Study of BRII-297 in Healthy Adult Subjects · Phase 1 · completed
NCT04787211 — A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 · Phase 2 · completed
NCT04749368 — Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B V · Phase 2 · completed
NCT04691180 — A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04507269 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brii Biosciences Limited
Last refreshed: 26 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04507269.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04507269

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of VIR-2218

Other recruiting trials for Hepatitis B, Chronic

Other Brii Biosciences Limited trials

Verify against primary sources