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

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03672188
Collaborator
Alnylam Pharmaceuticals (Industry)
82
Enrollment
14
Locations
15
Arms
21.7
Actual Duration (Months)
5.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Actual Study Start Date :
Nov 14, 2018
Actual Primary Completion Date :
Sep 3, 2020
Actual Study Completion Date :
Sep 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: SAD VIR-2218 50 mg

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Part A: SAD VIR-2218 100 mg

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Part A: SAD VIR-2218 200 mg

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Part A: SAD VIR-2218 400 mg

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Part A: SAD VIR-2218 600 mg

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Part A: SAD VIR-2218 900 mg

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Placebo Comparator: Part A: SAD Placebo

Healthy subjects received a single dose of placebo administered SC

Drug: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: 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.

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Placebo Comparator: Part B: MAD Placebo

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Drug: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Placebo Comparator: Part C: MAD Placebo

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Drug: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 364 days]

    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.

  2. Clinical Assessments Including But Not Limited to Laboratory Test Results [Up to 336 days]

    Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

Secondary Outcome Measures

  1. Maximum Plasma Concentration (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]

    VIR-2218 and metabolite Maximum Concentration in Plasma

  2. Time to Reach Maximum Plasma Concentration (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]

    VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3)

  3. Area Under the Plasma Concentration Versus Time Curve (ng*h/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]

    VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time

  4. Apparent Terminal Elimination Half-life (h) [Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1]

    VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3)

  5. Apparent Plasma Clearance (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]

    VIR-2218 CL/F Apparent plasma clearance

  6. Apparent Volume of Distribution (L) [Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1]

    VIR-2218 VZ/F apparent volume of distribution

  7. Urine %fe 0-24h [Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)]

    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.

  8. Apparent Renal Clearance (CLR/F) [Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)]

    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.

  9. Maximum Reduction of Serum HBsAg From Baseline [Up to 112 days]

    Maximum reduction of serum HBsAg from Day 1 until Week 16.

  10. Number of Subjects With Serum HBsAg Loss at Any Time Point [Up to 336 days]

    Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements

  11. Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months [Up to 336 days]

    Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements

  12. Number of Subjects With Anti-HBs Seroconversion at Any Timepoint [Up to 336 days]

    Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements

  13. Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint [Up to 336 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site Birtinya Queensland Australia 4575
2 Investigative Site Clayton Victoria Australia 3168
3 Investigative Site Fitzroy Victoria Australia 3065
4 Investigative Site Hong Kong Hong Kong
5 Investigative Site Busan Korea, Republic of 49241
6 Investigative Site Seoul Korea, Republic of 03080
7 Investigative Site Seoul Korea, Republic of 05505
8 Investigative Site Auckland New Zealand 1010
9 Investigative Site Auckland New Zealand 2025
10 Investigative Site Bangkok Thailand 10330
11 Investigative Site Bangkok Thailand 10400
12 Investigative Site Bangkok Thailand 10700
13 Investigative Site Hat Yai Thailand 90110
14 Investigative Site Khon Kaen Thailand 40002

Sponsors and Collaborators

  • Vir Biotechnology, Inc.
  • Alnylam Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT03672188
Other Study ID Numbers:
  • VIR-2218-1001
First Posted:
Sep 14, 2018
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Vir Biotechnology, Inc.
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD 200 mg Part B: MAD Placebo Part C: MAD Placebo
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection 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 placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection 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 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 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 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 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 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 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 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
Period Title: Overall Study
STARTED 6 6 6 8 6 6 12 3 6 6 3 3 3 6 2
Dosed 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2
COMPLETED 6 6 5 5 6 6 12 3 6 6 3 3 2 6 2
NOT COMPLETED 0 0 1 3 0 0 0 0 0 0 0 0 1 0 0

Baseline Characteristics

Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo Total
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection 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 placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection 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 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 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 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 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 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 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 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 Total of all reporting groups
Overall Participants 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2 81
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
25
(3)
23.3
(4)
26.7
(3.8)
24.3
(3.7)
28.8
(6.3)
32.5
(9.5)
26.5
(6.7)
40.3
(9.1)
42.5
(10.8)
45.2
(5.5)
55
(4)
35
(9.8)
33.7
(13.1)
44
(7.2)
58.5
(7.8)
33.4
(11.5)
Sex: Female, Male (Count of Participants)
Female
6
100%
4
66.7%
3
50%
7
100%
3
50%
3
50%
5
41.7%
1
33.3%
1
16.7%
1
16.7%
3
100%
2
66.7%
1
33.3%
3
50%
1
50%
44
54.3%
Male
0
0%
2
33.3%
3
50%
0
0%
3
50%
3
50%
7
58.3%
2
66.7%
5
83.3%
5
83.3%
0
0%
1
33.3%
2
66.7%
3
50%
1
50%
37
45.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
1
8.3%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
2.5%
Not Hispanic or Latino
6
100%
6
100%
6
100%
7
100%
6
100%
5
83.3%
11
91.7%
3
100%
6
100%
6
100%
3
100%
3
100%
3
100%
6
100%
2
100%
79
97.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
2
33.3%
3
50%
0
0%
0
0%
2
33.3%
1
16.7%
1
8.3%
3
100%
5
83.3%
5
83.3%
3
100%
3
100%
3
100%
6
100%
2
100%
39
48.1%
Native Hawaiian or Other Pacific Islander
1
16.7%
1
16.7%
0
0%
1
14.3%
0
0%
0
0%
2
16.7%
0
0%
1
16.7%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
6
7.4%
Black or African American
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
White
2
33.3%
2
33.3%
5
83.3%
5
71.4%
3
50%
3
50%
8
66.7%
0
0%
0
0%
1
16.7%
0
0%
0
0%
0
0%
0
0%
0
0%
29
35.8%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
1
16.7%
0
0%
1
16.7%
1
14.3%
1
16.7%
2
33.3%
1
8.3%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
7
8.6%
Region of Enrollment (participants) [Number]
New Zealand
6
100%
6
100%
6
100%
7
100%
6
100%
6
100%
12
100%
0
0%
2
33.3%
1
16.7%
0
0%
1
33.3%
0
0%
0
0%
1
50%
54
66.7%
South Korea
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
1
16.7%
2
33.3%
2
66.7%
1
33.3%
0
0%
1
16.7%
0
0%
8
9.9%
Hong Kong
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
3
50%
0
0%
0
0%
1
33.3%
1
33.3%
2
33.3%
0
0%
8
9.9%
Australia
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
33.3%
0
0%
0
0%
2
66.7%
0
0%
0
0%
4
4.9%
Thailand
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
33.3%
0
0%
1
16.7%
1
33.3%
0
0%
0
0%
3
50%
1
50%
7
8.6%
Hepatitis B Surface Antigen Levels (IU/mL) (IU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [IU/mL]
2372.227
(1168.940)
3872.625
(5678.292)
4009.863
(5239.703)
2374.423
(2078.034)
3488.037
(2454.215)
12640.983
(10495.983)
4819.127
(6348.594)
1886.045
(1223.655)
4456.52
(5657.74)
Alanine Aminotransferase Levels (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]
15.3
(4.6)
23.5
(14.9)
14.3
(5.0)
10.0
(4.0)
27.7
(18.6)
26.0
(17.7)
21.8
(17.6)
26.5
(10.6)
20.25
(13.08)

Outcome Measures

1. Primary Outcome
Title Incidence of Adverse Events (AEs)
Description 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.
Time Frame Up to 364 days

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2219 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection 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 placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection 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 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 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 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 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 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 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 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
Measure Participants 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2
Count of Participants [Participants]
4
66.7%
3
50%
4
66.7%
5
71.4%
3
50%
3
50%
6
50%
0
0%
2
33.3%
5
83.3%
2
66.7%
2
66.7%
2
66.7%
1
16.7%
1
50%
2. Primary Outcome
Title Clinical Assessments Including But Not Limited to Laboratory Test Results
Description Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Time Frame Up to 336 days

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection 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 placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection 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 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 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 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 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 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 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 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
Measure Participants 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2
CTCAE v5.0 Lab Grade 0
1
16.7%
1
16.7%
1
16.7%
1
14.3%
1
16.7%
0
0%
1
8.3%
1
33.3%
0
0%
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
CTCAE v5.0 Lab Grade 1
3
50%
3
50%
3
50%
4
57.1%
4
66.7%
3
50%
7
58.3%
2
66.7%
4
66.7%
5
83.3%
3
100%
3
100%
3
100%
3
50%
2
100%
CTCAE v5.0 Lab Grade 2
1
16.7%
2
33.3%
1
16.7%
1
14.3%
1
16.7%
3
50%
3
25%
0
0%
2
33.3%
1
16.7%
0
0%
0
0%
0
0%
2
33.3%
0
0%
CTCAE v5.0 Lab Grade 3
1
16.7%
0
0%
0
0%
0
0%
0
0%
0
0%
1
8.3%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
CTCAE v5.0 Lab Grade 4
0
0%
0
0%
0
0%
1
14.3%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Clinically Significant Vital Signs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Clinically Significant ECG
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
3. Secondary Outcome
Title Maximum Plasma Concentration (ng/mL)
Description VIR-2218 and metabolite Maximum Concentration in Plasma
Time Frame 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

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20 mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Parts B/C: MAD VIR-2218 200 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 6 5 6 6 6 6 3 9 6 6
VIR-2218 Cmax (Day 1)
155
(65.3)
355
(117)
711
(207)
2110
(722)
1830
(615)
5010
(630)
73.5
(NA)
118
(61.2)
235
(79.0)
826
(336)
AS (N-1)3' VIR-2218 Cmax (Day 1)
NA
(NA)
40.5
(NA)
62.4
(17.6)
259
(114)
177
(99.2)
514
(106)
NA
(NA)
NA
(NA)
NA
(NA)
66.1
(NA)
VIR-2218 Cmax (Day 29)
51.8
(21.1)
115
(38.2)
256
(167)
807
(374)
AS (N-1)3' VIR-2218 Cmax (Day 29)
NA
(NA)
NA
(NA)
NA
(NA)
75.1
(27.2)
4. Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (h)
Description VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3)
Time Frame 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

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20 mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Part B/C: MAD VIR-2218 200 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 6 5 6 6 6 6 3 9 6 6
VIR-2218 Tmax Day 1
4.25
4.32
5.21
7.21
7.21
4.25
4.00
7.63
2.48
5.98
AS(N-1)3' VIR-2218 Tmax Day 1
NA
6.17
6.17
9.21
10.2
8.25
NA
NA
NA
8.00
VIR-2218 Tmax Day 29
3.95
4.00
8.00
3.99
AS (N-1)3' VIR-2218 Tmax Day 29
NA
NA
6.00
5.99
5. Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)
Description VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time
Time Frame 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

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Part B/C: MAD VIR-2218 200 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 6 5 6 6 6 6 3 9 6 6
VIR-2218 AUClast (Day 1)
1270
(270)
3740
(1190)
6630
(1160)
23500
(2700)
27900
(7540)
58800
(9070)
360
(199)
1000
(285)
2700
(943)
9570
(2410)
AS(N-1) 3' VIR-2218 AUClast (Day 1)
NA
(NA)
208
(190)
481
(149)
2530
(613)
2680
(1460)
6430
(1500)
NA
(NA)
NA
(NA)
NA
(NA)
482
(199)
VIR-2218 AUClast (Day 29)
339
(171)
910
(326)
2550
(638)
9580
(3240)
AS(N-1) 3' VIR-2218AUClast (Day 29)
NA
(NA)
NA
(NA)
174
(NA)
393
(230)
6. Secondary Outcome
Title Apparent Terminal Elimination Half-life (h)
Description VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3)
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 5 4 5 6 6 6
Median (Inter-Quartile Range) [h]
2.45
3.64
4.38
3.54
5.28
4.55
7. Secondary Outcome
Title Apparent Plasma Clearance (L/h)
Description VIR-2218 CL/F Apparent plasma clearance
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 5 4 5 6 6 6
Mean (Standard Deviation) [L/h]
34.0
(2.54)
21.8
(4.27)
30.8
(4.51)
16.8
(1.76)
21.9
(6.91)
15.3
(2.08)
8. Secondary Outcome
Title Apparent Volume of Distribution (L)
Description VIR-2218 VZ/F apparent volume of distribution
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 5 4 5 6 6 6
Mean (Standard Deviation) [L]
155
(69.7)
132
(40.7)
223
(76.0)
104
(62.6)
176
(60.8)
92.9
(24.6)
9. Secondary Outcome
Title Urine %fe 0-24h
Description 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.
Time Frame Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 6 5 6 6 6 6
VIR-2218 fe 0-24
16.9
(3.19)
21.7
(6.22)
23.2
(4.34)
29.5
(5.72)
32.3
(11.7)
47.6
(8.59)
AS(N-1)3' VIR-2218 fe 0-24
1.94
(0.480)
4.16
(2.28)
3.31
(0.656)
4.99
(0.740)
4.12
(2.31)
6.96
(1.47)
10. Secondary Outcome
Title Apparent Renal Clearance (CLR/F)
Description 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.
Time Frame Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)

Outcome Measure Data

Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 5 4 5 6 6 6
Mean (Standard Deviation) [L/h]
5.87
(0.728)
5.22
(1.27)
7.00
(0.659)
5.13
(0.850)
7.22
(1.480)
7.47
(1.340)
11. Secondary Outcome
Title Maximum Reduction of Serum HBsAg From Baseline
Description Maximum reduction of serum HBsAg from Day 1 until Week 16.
Time Frame Up to 112 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Arm/Group Description 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 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 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 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 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 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 Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart VIR-2218: VIR-2218 given by subcutaneous injection
Measure Participants 3 6 6 3 3 3 6 2
Mean (Standard Deviation) [log10 IU/mL]
-1.031
(0.574)
-1.230
(0.702)
-1.504
(0.540)
-1.653
(0.154)
-1.161
(0.350)
-1.568
(0.636)
-0.098
(0.047)
-0.068
(0.01)
12. Secondary Outcome
Title Number of Subjects With Serum HBsAg Loss at Any Time Point
Description Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Time Frame Up to 336 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Arm/Group Description 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 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 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 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 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 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 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 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
Measure Participants 3 6 6 3 3 3 6 2
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
13. Secondary Outcome
Title Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months
Description Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Time Frame Up to 336 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Arm/Group Description 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 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 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 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 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 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 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 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
Measure Participants 3 6 6 3 3 3 6 2
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
14. Secondary Outcome
Title Number of Subjects With Anti-HBs Seroconversion at Any Timepoint
Description Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements
Time Frame Up to 336 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Arm/Group Description 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 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 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 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 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 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 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 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
Measure Participants 3 6 6 3 3 3 6 2
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
15. Secondary Outcome
Title Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
Description 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
Time Frame Up to 336 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part C MAD: Placebo
Arm/Group Description 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 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 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
Measure Participants 3 3 2
Number of Subjects with HBeAg Loss
0
0%
1
16.7%
0
0%
Number of Subjects with anti-HBe seroconversion
0
0%
1
16.7%
0
0%

Adverse Events

Time Frame Up to 364 days after first dose with VIR-2218 or placebo
Adverse Event Reporting Description 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.
Arm/Group Title Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Arm/Group Description Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 100 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 Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC VIR-2218: VIR-2218 given by subcutaneous injection 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 placebo administered SC Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection 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 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 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 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 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 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 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 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
All Cause Mortality
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/2 (0%)
Serious Adverse Events
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Nervous system disorders
Headache 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Other (Not Including Serious) Adverse Events
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/6 (66.7%) 3/6 (50%) 4/6 (66.7%) 5/7 (71.4%) 3/6 (50%) 3/6 (50%) 6/12 (50%) 0/3 (0%) 2/6 (33.3%) 5/6 (83.3%) 2/3 (66.7%) 2/3 (66.7%) 2/3 (66.7%) 1/6 (16.7%) 1/2 (50%)
Cardiac disorders
Palpitations 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Gastrointestinal disorders
Abdominal discomfort 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Abdominal pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Abdominal pain upper 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Constipation 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Nausea 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Paraesthesia oral 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Toothache 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Vomiting 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
General disorders
Catheter site pain 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Fatigue 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 2/6 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Influenza like illness 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/2 (0%)
Injection site bruising 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 2/6 (33.3%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Injection site discomfort 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Injection site pain 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/7 (14.3%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Night sweats 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Pyrexia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Infections and infestations
Gastroenteritis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Influenza 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Respiratory tract infection 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Upper respiratory tract infection 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 2/12 (16.7%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Viral infection 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Viral upper respiratory tract 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Injury, poisoning and procedural complications
Contusion 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Eye contusion 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Limb injury 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Muscle strain 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Investigations
Cardiac murmur 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/2 (50%)
Metabolism and nutrition disorders
Dehydration 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Hypophosphataemia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Myalgia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/2 (0%)
Neck pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Nervous system disorders
Dizziness 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%) 0/3 (0%) 0/6 (0%) 2/6 (33.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Headache 1/6 (16.7%) 3/6 (50%) 2/6 (33.3%) 2/7 (28.6%) 0/6 (0%) 1/6 (16.7%) 2/12 (16.7%) 0/3 (0%) 1/6 (16.7%) 2/6 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 0/6 (0%) 0/2 (0%)
Hypoaesthesia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/2 (0%)
Lethargy 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Renal and urinary disorders
Urinary tract infection 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Dry throat 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Epistaxis 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Oropharyngeal pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 1/12 (8.3%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Rhinorrhoea 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/2 (0%)
Sneezing 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Rash 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)
Urticaria 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/3 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigators may discuss or publish results after: the study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 2 years provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s)

Results Point of Contact

Name/Title Study Inquiry
Organization Vir Biotechnology, Inc.
Phone 415-654-5281
Email clinicaltrials@vir.bio
Responsible Party:
Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT03672188
Other Study ID Numbers:
  • VIR-2218-1001
First Posted:
Sep 14, 2018
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021