Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients

Recruitment & Eligibility

Inclusion Criteria

All population:

Chinese population
Adequate hematological function: platelet count greater than or equal to (>=) 100*10^9 per liter (/L), hemoglobin (Hb) >= 12 grams/deciliter (g/dL) (male) or >= 11 g/dL (female), white blood cell (WBC) count >= 4*10^9/L and <= 11*10^9/L

Healthy volunteers:

Absence of evidence of any active or chronic disease
Negative hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antiody (HBeAb) and hepatitis B core antibody (HBcAb)
Adequate liver function: transaminases alanine aminotransferase (ALT) <= 1.0 times the upper limit of normal (ULN)

Treatment naïve CHB patients:

HBsAg-positive (>=250 international unit/milliliter [IU/mL]), compensated liver function, non-cirrhotic
HBeAg-positive, HBV DNA >= 200,000 IU/ml or equivalent copies/mL, ALT >1.5 times the ULN and ALT <8 times the ULN

HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:

Subjects who HBeAg-seroconverted on nucleoside/nucleotide analogue therapy (treatment for 1 to 3 years prior to enrollment) with HBV DNA <90 IU/mL or below a detection level acceptable by both the sponsor and investigator for at least the preceding 6 months; HBeAg negative and HBeAb positive
HBsAg-positive (>=250 IU/mL), compensated liver function, non-cirrhotic -ALT <= 1*ULN

Exclusion Criteria

Use of steroids or other immune suppressive agents within the last 4 weeks that would impact the number/functions of white blood cells (WBC)
Any other diseases or clinical laboratory finding giving reasonable suspicion of a disease or condition (including, but not limited to, cancer, lupus erythematosus, rheumatoid arthritis, or other autoimmune disease) that could confound the result of the study
Positive Hepatitis A immunoglobulin M (IgM) antibody, Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV) at screening
Significant acute infection, example; influenza, acute gastrointestinal symptoms or any other clinically significant illness within 2 weeks
Previous/concurrent treatment with interferon-based therapy for CHB

Study & Design

Primary Outcome Measures

Name	Time	Method
Cytokine/chemokine production	Day 1
Induction of interferon-responsive genes	Day 1
Correlation coefficients between baseline toll-like receptor 7 (TLR7) expression and ex vivo immune response upon stimulation of PBMCs with RO6871765 or RO7011785 (in terms of cytokine release and gene expression)	Day 1

Secondary Outcome Measures

Name	Time	Method
Ex-vivo antiviral activity of PBMC supernatant	Day 1
Number or percentages of B-lymphocytes in healthy volunteers and subjects with CHB	Screening up to Day 1
Number or percentages of myeloid dendritic cells (mDCs) in healthy volunteers and subjects with CHB	Screening up to Day 1
Number or percentages of T-lymphocytes in healthy volunteers and subjects with CHB	Screening Up to Day 1
Number or percentages of natural killer (NK) -cells in healthy volunteers and subjects with CHB	Screening up to Day 1
Number or percentages of plasmacytoid dendritic cells (pDCs) in healthy volunteers and subjects with CHB	Screening up to Day 1

Recruitment & Eligibility