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| Name | Class |
|---|---|
| Alnylam Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD VIR-2218 50 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC |
|
| Part A: SAD VIR-2218 100 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC |
|
| Part A: SAD VIR-2218 200 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC |
|
| Part A: SAD VIR-2218 400 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC |
|
| Part A: SAD VIR-2218 600 mg | Experimental | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC |
|
| Part A: SAD VIR-2218 900 mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort. | Up to 364 days |
| Clinical Assessments Including But Not Limited to Laboratory Test Results | Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | Up to 336 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (ng/mL) | VIR-2218 and metabolite Maximum Concentration in Plasma | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
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Part A SAD:
Inclusion Criteria:
Exclusion Criteria:
Parts B/C MAD:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Birtinya | Queensland | 4575 | Australia | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389081 | Derived | Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8. | |
| 37290591 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: SAD VIR-2218 50 mg | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| FG001 | Part A: SAD VIR-2218 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2019 | Oct 19, 2021 |
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Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC
|
| Part A: SAD Placebo | Placebo Comparator | Healthy subjects received a single dose of placebo administered SC |
|
| Part B: MAD VIR-2218 20 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. |
|
| Part B: MAD VIR-2218 50 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
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| Part B: MAD VIR-2218 100 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. |
|
| Part B: MAD VIR-2218 200 mg | Experimental | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
|
| Part C: MAD VIR-2218 50 mg | Experimental | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
|
| Part C: MAD VIR-2218 200 mg | Experimental | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
|
| Part B: MAD Placebo | Placebo Comparator | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. |
|
| Part C: MAD Placebo | Placebo Comparator | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. |
|
| Placebo | Drug | Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
|
| Time to Reach Maximum Plasma Concentration (h) |
VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3) |
| Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
| Area Under the Plasma Concentration Versus Time Curve (ng*h/mL) | VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
| Apparent Terminal Elimination Half-life (h) | VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3) | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1 |
| Apparent Plasma Clearance (L/h) | VIR-2218 CL/F Apparent plasma clearance | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1 |
| Apparent Volume of Distribution (L) | VIR-2218 VZ/F apparent volume of distribution | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1 |
| Urine %fe 0-24h | VIR-2218 and metabolite: Fraction excreted in the urine from time 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, fraction excreted in the urine ( %fe 0-24h ) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures. | Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs) |
| Apparent Renal Clearance (CLR/F) | VIR-2218 Apparent renal clearance from 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, apparent renal clearance (CLR/F) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures. | Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs) |
| Maximum Reduction of Serum HBsAg From Baseline | Maximum reduction of serum HBsAg from Day 1 until Week 16. | Up to 112 days |
| Number of Subjects With Serum HBsAg Loss at Any Time Point | Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements | Up to 336 days |
| Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months | Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements | Up to 336 days |
| Number of Subjects With Anti-HBs Seroconversion at Any Timepoint | Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements | Up to 336 days |
| Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint | HBeAg loss is defined as quantitative HBeAg < 0.11 IU/mL at two or more consecutive measurements. anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements | Up to 336 days |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Investigative Site | Fitzroy | Victoria | 3065 | Australia |
| Investigative Site | Hong Kong | Hong Kong |
| Investigative Site | Auckland | 1010 | New Zealand |
| Investigative Site | Auckland | 2025 | New Zealand |
| Investigative Site | Busan | 49241 | South Korea |
| Investigative Site | Seoul | 03080 | South Korea |
| Investigative Site | Seoul | 05505 | South Korea |
| Investigative Site | Bangkok | 10330 | Thailand |
| Investigative Site | Bangkok | 10400 | Thailand |
| Investigative Site | Bangkok | 10700 | Thailand |
| Investigative Site | Hat Yai | 90110 | Thailand |
| Investigative Site | Khon Kaen | 40002 | Thailand |
| Derived |
| Gane E, Lim YS, Kim JB, Jadhav V, Shen L, Bakardjiev AI, Huang SA, Cathcart AL, Lempp FA, Janas MM, Cloutier DJ, Kaittanis C, Sepp-Lorenzino L, Hinkle G, Taubel J, Haslett P, Milstein S, Anglero-Rodriguez YI, Hebner CM, Pang PS, Yuen MF. Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials. J Hepatol. 2023 Oct;79(4):924-932. doi: 10.1016/j.jhep.2023.05.023. Epub 2023 Jun 7. |
| 34741731 | Derived | Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6. |
Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC
VIR-2218: VIR-2218 given by subcutaneous injection
| FG002 | Part A: SAD VIR-2218 200 mg | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| FG003 | Part A: SAD VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| FG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| FG005 | Part A SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| FG006 | Part A: SAD Placebo | Healthy subjects received a single dose of placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| FG007 | Part B: MAD VIR-2218 20 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| FG008 | Part B: MAD VIR-2218 50 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| FG009 | Part B: MAD VIR-2218 100 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| FG010 | Part B: MAD VIR-2218 200 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| FG011 | Part C: MAD VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| FG012 | Part C: MAD 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| FG013 | Part B: MAD Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| FG014 | Part C: MAD Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| Dosed |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The Overall Number of Baseline Participants is not consistent with numbers provided in the rows of the Participant Flow module because we enrolled and randomized 8 participants for the Part A 400 mg cohort, but only 7 of these participants were dosed and included for full analysis dataset. We have added a row for dosed participants in the Participant Flow module, to clarify this inconsistency and reflect the number of participants in the analysis dataset.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: SAD VIR-2218 50 mg | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG001 | Part A: SAD VIR-2218 100 mg | Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG002 | Part A: SAD VIR-2218 200 mg | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG003 | Part A: SAD VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| BG006 | Part A: SAD Placebo | Healthy subjects received a single dose of placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| BG007 | Part B: MAD VIR-2218 20 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG008 | Part B: MAD VIR-2218 50 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG009 | Part B: MAD VIR-2218 100 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG010 | Part B: MAD VIR-2218 200 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG011 | Part C: MAD VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG012 | Part C: MAD VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| BG013 | Part B: MAD Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| BG014 | Part C: MAD Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| BG015 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Hepatitis B Surface Antigen Levels (IU/mL) | HBsAg Levels seen across dose levels for Chronic Hepatitis B Subjects. | HBsAg levels would not be seen in Healthy subjects population, therefore 0 subjects were analyzed in corresponding dose levels. | Mean | Standard Deviation | IU/mL |
| ||||||||
| Alanine Aminotransferase Levels | Alanine Aminotransferase Levels in Chronic Hepatitis B Subjects | Alanine Aminotransferase Levels were not analyzed in Healthy subjects population. | Mean | Standard Deviation | U/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort. | The Overall Number of Participants Analyzed is not consistent with numbers provided in the rows of the Participant Flow module because we enrolled and randomized 8 participants for the Part A 400 mg cohort, but only 7 of these participants were dosed and included for full analysis dataset. We have added a row for dosed participants in the Participant Flow module, to clarify this inconsistency and reflect the number of participants in the analysis dataset. | Posted | Count of Participants | Participants | Up to 364 days |
|
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| Primary | Clinical Assessments Including But Not Limited to Laboratory Test Results | Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | Number of participants analyzed is inclusive of clinically significant Vital Signs, ECGs, and Lab Findings. The Overall Number of Participants Analyzed is not consistent with numbers provided in the rows of the Participant Flow module. This inconsistency has been explained in the Analysis Population Description in our First Primary Outcome Measure as well. | Posted | Count of Participants | Participants | Up to 336 days |
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| Secondary | Maximum Plasma Concentration (ng/mL) | VIR-2218 and metabolite Maximum Concentration in Plasma | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | ng/mL | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
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| Secondary | Time to Reach Maximum Plasma Concentration (h) | VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3) | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Median | Inter-Quartile Range | h | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve (ng*h/mL) | VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | h*ng/mL | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5 |
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| Secondary | Apparent Terminal Elimination Half-life (h) | VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3) | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Median | Inter-Quartile Range | h | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1 |
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| Secondary | Apparent Plasma Clearance (L/h) | VIR-2218 CL/F Apparent plasma clearance | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | L/h | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1 |
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| Secondary | Apparent Volume of Distribution (L) | VIR-2218 VZ/F apparent volume of distribution | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | L | Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1 |
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| Secondary | Urine %fe 0-24h | VIR-2218 and metabolite: Fraction excreted in the urine from time 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, fraction excreted in the urine ( %fe 0-24h ) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures. | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | % excreted in the urine from time 0-24h | Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs) |
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| Secondary | Apparent Renal Clearance (CLR/F) | VIR-2218 Apparent renal clearance from 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, apparent renal clearance (CLR/F) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures. | The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter | Posted | Mean | Standard Deviation | L/h | Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Reduction of Serum HBsAg From Baseline | Maximum reduction of serum HBsAg from Day 1 until Week 16. | Posted | Mean | Standard Deviation | log10 IU/mL | Up to 112 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serum HBsAg Loss at Any Time Point | Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements | Posted | Count of Participants | Participants | Up to 336 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months | Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements | Posted | Count of Participants | Participants | Up to 336 days |
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| Secondary | Number of Subjects With Anti-HBs Seroconversion at Any Timepoint | Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements | Posted | Count of Participants | Participants | Up to 336 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint | HBeAg loss is defined as quantitative HBeAg < 0.11 IU/mL at two or more consecutive measurements. anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements | Posted | Count of Participants | Participants | Up to 336 days |
|
|
Up to 364 days after first dose with VIR-2218 or placebo
The Total Number of Participants at Risk - All Cause Mortality, Serious Adverse Events, and Other (Not Including Adverse Events) tables - is not consistent with numbers provided in the rows of the Participant Flow module. This inconsistency has been explained in the Baseline Analysis Population Description.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A SAD: VIR-2218 50 mg | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 4 | 6 |
| EG001 | Part A SAD: VIR-2218 100 mg | Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Part A SAD: VIR-2218 200 mg | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Part A SAD: VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 7 | 0 | 7 | 5 | 7 |
| EG004 | Part A SAD: VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Part A SAD: VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | Part A SAD: Placebo | Healthy subjects received a single dose of placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection | 0 | 12 | 0 | 12 | 6 | 12 |
| EG007 | Part B MAD: VIR-2218 20 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | Part B MAD: VIR-2218 50 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | Part B MAD: VIR-2218 100 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 6 | 1 | 6 | 5 | 6 |
| EG010 | Part B MAD: VIR-2218 200 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 3 | 0 | 3 | 2 | 3 |
| EG011 | Part C MAD: VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 0 | 3 | 0 | 3 | 2 | 3 |
| EG012 | Part C MAD: VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection | 1 | 3 | 0 | 3 | 2 | 3 |
| EG013 | Part B MAD: Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection | 0 | 6 | 0 | 6 | 1 | 6 |
| EG014 | Part C MAD: Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection | 0 | 2 | 0 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Paraesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Catheter site pain | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Influenza like illness | General disorders | Non-systematic Assessment |
| ||
| Injection site bruising | General disorders | Non-systematic Assessment |
| ||
| Injection site discomfort | General disorders | Non-systematic Assessment |
| ||
| Injection site pain | General disorders | Non-systematic Assessment |
| ||
| Night sweats | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Viral upper respiratory tract | Infections and infestations | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Eye contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Cardiac murmur | Investigations | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Medial tibial stress syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dry throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Investigators may discuss or publish results after:
Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Vir Biotechnology, Inc. | 415-654-5281 | clinicaltrials@vir.bio |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2020 | Oct 19, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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| South Korea |
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| Hong Kong |
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| Australia |
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| Thailand |
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| OG003 | Part A: SAD VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part A: SAD Placebo | Healthy subjects received a single dose of placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| OG007 | Part B: MAD VIR-2218 20 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG008 | Part B: MAD VIR-2218 50 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG009 | Part B: MAD VIR-2218 100 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG010 | Part B: MAD VIR-2218 200 mg | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG011 | Part C: MAD VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG012 | Part C: MAD VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG013 | Part B: MAD Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| OG014 | Part C: MAD Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
|
|
Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B/C: MAD VIR-2218 20 mg | Chronic HBV subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG007 | Part B/C: MAD VIR-2218 50 mg | Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG008 | Part B/C: MAD VIR-2218 100 mg | Chronic HBV, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG009 | Parts B/C: MAD VIR-2218 200 mg | Chronic HBV subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| Part A: SAD VIR-2218 400 mg |
Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B/C: MAD VIR-2218 20 mg | Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG007 | Part B/C: MAD VIR-2218 50 mg | Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG008 | Part B/C: MAD VIR-2218 100 mg | Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG009 | Part B/C: MAD VIR-2218 200 mg | Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| Part A: SAD VIR-2218 400 mg |
Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B/C: MAD VIR-2218 20mg | Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG007 | Part B/C: MAD VIR-2218 50 mg | Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG008 | Part B/C: MAD VIR-2218 100 mg | Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG009 | Part B/C: MAD VIR-2218 200 mg | Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC
VIR-2218: VIR-2218 given by subcutaneous injection
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC
VIR-2218: VIR-2218 given by subcutaneous injection
| OG003 | Part A SAD: VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A SAD: VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A SAD: VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| OG003 | Part A: SAD VIR-2218 400 mg | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG004 | Part A: SAD VIR-2218 600 mg | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part A: SAD VIR-2218 900 mg | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| OG004 | Part C MAD: VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part C MAD: VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B MAD: Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
| OG007 | Part C MAD: Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection |
|
|
| OG004 | Part C MAD: VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part C MAD: VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B MAD: Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| OG007 | Part C MAD: Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
|
|
| OG004 | Part C MAD: VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part C MAD: VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B MAD: Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| OG007 | Part C MAD: Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
|
|
| OG004 | Part C MAD: VIR-2218 50 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG005 | Part C MAD: VIR-2218 200 mg | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection |
| OG006 | Part B MAD: Placebo | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| OG007 | Part C MAD: Placebo | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
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| Participants |
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