Pharmacokinetics of New HepBQuin

Inclusion criteria

• Healthy volunteers, male and female, aged 18 to 65 inclusive.
• Negative serology test for HBsAg, anti-HBs, and anti-HBc at screening.
• Body-mass index (BMI) of 18.5 to 32.0 kg/m2 (inclusive).
• Female volunteers must have a pregnancy test at screening.
• Willing to participate by signing the written signed informed consent form.

Exclusion criteria

• Vaccinated against Hepatitis B
• Having a Hepatitis B infection or suffered from a Hepatitis B infection in the past.
• Known with allergic reactions against human plasma, plasma products or blood products.
• A history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
• Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Known with or having a history of arterial or venous thromboembolic events.
• Pre-existing risk factors for thrombotic events.
• Any clinically significant history of or current clinically significant other disease or disorder.
• Any clinically significant abnormality following the investigator's review of physical examination, and clinical laboratory tests obtained at screening.
• An abnormal pulse rate and/or blood pressure measurements at the screening visit.
• Pregnant or breast-feeding at screening or at Day 0
• Women of childbearing potential not using a highly effective method of birth.
• Any use of drugs or abuse within 3 months prior to screening and during study.
• Alcohol abuse within 3 months prior to screening and during study
• Participated in another interventional clinical trial a month before the start of the study, or having received an experimental drug during the previous 30 days.
• Having IgA deficiency with anti-IgA antibodies.
• Blood or plasma donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial.