None listed
Conditions
Brief summary
This is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.
Interventions
A qualified study site staff member under the supervision of the investigator of designee will administer study drug to participants via IM injection.
Cohort A will serve as the control.
Cohort B participants will receive an intramuscular (IM) injection of 20 microgram BRII-179 (VBI- 2601) per dose on Day 1, Week 4, Week 8 and Week 12
Cohort C participants will receive an IM injection of 20 microgram BRII-179 (VBI-2601) admixed with 3M International units of Interferon alpha(IFN-a) on Day 1, We
A qualified study site staff member under the supervision of the investigator of designee will administer study drug to participants via IM injection. Cohort A will serve as the control. Cohort B participants will receive an intramuscular (IM) injection of 20 microgram BRII-179 (VBI- 2601) per dose on Day 1, Week 4, Week 8 and Week 12 Cohort C participants will receive an IM injection of 20 microgram BRII-179 (VBI-2601) admixed with 3M International units of Interferon alpha(IFN-a) on Day 1, Week 4, Week 8 and Week 12 Cohort D participants will receive an IM injection of 40 microgram BRII-179 (VBI-2601) per dose on Day 1 Week 4, Week 8 and Week 12. Cohort E participants will receive an IM injection of 40 microgram BRII-179 (VBI-2601) admixed with 3 MIU of IFN-a on Day 1, Week 4, Week 8 and Week 12. Site of the intramuscular injection: Intramuscularly (IM) in deltoid muscle of right or left upper arm (alternated between each immunisation) Participants will undergo either Part 1 or Part 2; participants of Cohort A (of Part 1) can participate in any Cohort of Part 2 after Week 16, if they wish to. All other cohort participants will only enrol to one Cohort of either Part 1 or Part 2.
Sponsors
Brii Biosciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1) Male or female age 18 to 60 2) BMI 18 to 32 kg per meter 2 3) Chronic HBV infection for greater than or equal 6 months
Exclusion criteria
1) Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation 2) Significant fibrosis or cirrhosis 3) History or evidence of drug or alcohol abuse 4) History of intolerance to intramuscular injection 5) History of chronic liver disease from any cause other than chronic HBV infection 6) History of hepatic decompensation
Outcome results
None listed