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Completed

NCT Number: NCT03672188

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

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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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigative Site, Birtinya, Queensland, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Placebo

Drug

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

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: 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

    Time frame: 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 outcomes

  1. Maximum Plasma Concentration (ng/mL)

    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

    VIR-2218 and metabolite Maximum Concentration in Plasma

  2. Time to Reach Maximum Plasma Concentration (h)

    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

    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)

    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

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

  4. Apparent Terminal Elimination Half-life (h)

    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

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

  5. Apparent Plasma Clearance (L/h)

    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

    VIR-2218 CL/F Apparent plasma clearance

  6. Apparent Volume of Distribution (L)

    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

    VIR-2218 VZ/F apparent volume of distribution

  7. Urine %fe 0-24h

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Collaborators

  • Alnylam Pharmaceuticals

Registry information

Official study title

A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2018
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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