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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03672188




Registration number
NCT03672188
Ethics application status
Date submitted
11/09/2018
Date registered
14/09/2018
Date last updated
13/12/2021

Titles & IDs
Public title
Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B
Scientific title
A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218
Secondary ID [1] 0 0
VIR-2218-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIR-2218
Treatment: Drugs - Placebo

Experimental: Part A: SAD VIR-2218 50 mg - Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

Experimental: Part A: SAD VIR-2218 100 mg - Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

Experimental: Part A: SAD VIR-2218 200 mg - Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

Experimental: Part A: SAD VIR-2218 400 mg - Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

Experimental: Part A: SAD VIR-2218 600 mg - Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

Experimental: Part A: SAD VIR-2218 900 mg - Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

Placebo Comparator: Part A: SAD Placebo - Healthy subjects received a single dose of placebo administered SC

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.

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.

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.

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.

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.

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.

Placebo Comparator: Part B: MAD Placebo - Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo Comparator: Part C: MAD Placebo - Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.


Treatment: Drugs: VIR-2218
VIR-2218 given by subcutaneous injection

Treatment: Drugs: Placebo
Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 364 days
Primary outcome [2] 0 0
Clinical Assessments Including But Not Limited to Laboratory Test Results
Timepoint [2] 0 0
Up to 336 days
Secondary outcome [1] 0 0
Maximum Plasma Concentration (ng/mL)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Time to Reach Maximum Plasma Concentration (h)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Apparent Terminal Elimination Half-life (h)
Timepoint [4] 0 0
Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1
Secondary outcome [5] 0 0
Apparent Plasma Clearance (L/h)
Timepoint [5] 0 0
Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Secondary outcome [6] 0 0
Apparent Volume of Distribution (L)
Timepoint [6] 0 0
Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Secondary outcome [7] 0 0
Urine %fe 0-24h
Timepoint [7] 0 0
Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Secondary outcome [8] 0 0
Apparent Renal Clearance (CLR/F)
Timepoint [8] 0 0
Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Secondary outcome [9] 0 0
Maximum Reduction of Serum HBsAg From Baseline
Timepoint [9] 0 0
Up to 112 days
Secondary outcome [10] 0 0
Number of Subjects With Serum HBsAg Loss at Any Time Point
Timepoint [10] 0 0
Up to 336 days
Secondary outcome [11] 0 0
Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months
Timepoint [11] 0 0
Up to 336 days
Secondary outcome [12] 0 0
Number of Subjects With Anti-HBs Seroconversion at Any Timepoint
Timepoint [12] 0 0
Up to 336 days
Secondary outcome [13] 0 0
Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
Timepoint [13] 0 0
Up to 336 days

Eligibility
Key inclusion criteria
Part A SAD:



- Male or female age 18 - 55

- BMI 18 - 32 kg/m^2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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



- Any clinically significant chronic or acute medical condition that makes the volunteer
unsuitable for participation

- Significant fibrosis or cirrhosis

- History or evidence of drug or alcohol abuse

- History of intolerance to SC injection

- History of chronic liver disease from any cause other than chronic HBV infection

- History of hepatic decompensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2020
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site - Birtinya
Recruitment hospital [2] 0 0
Investigative Site - Clayton
Recruitment hospital [3] 0 0
Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Busan
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
Thailand
State/province [5] 0 0
Bangkok
Country [6] 0 0
Thailand
State/province [6] 0 0
Hat Yai
Country [7] 0 0
Thailand
State/province [7] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vir Biotechnology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Alnylam Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03672188
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03672188