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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03672188