Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Inclusion Criteria

• Male subjects from 18 to 55 years of age, inclusive, or female subjects from 18 to 65 years of age, inclusive
• Subjects with a body mass index (BMI) of 18.5 to 29.9 kg/m2
• Body weight greater than or equal to 50 kg at screening
• Subjects willing and able to provide written informed consent
• Subjects in good health in the judgment of the Investigator, as determined by medical history, physical examination, vital signs, ECG and laboratory assessments
• A female study subject must meet one of the following criteria:
• If a female of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to study treatment administration and during the entire study duration. An acceptable method of contraception includes one of the following:
• Abstinence from heterosexual intercourse (i.e. when abstinence is the preferred and usual lifestyle of the subject; periodic abstinence is not acceptable)
• Non-estrogen containing hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
• Intrauterine device without hormones
• Condom with spermicide
• Diaphragm or cervical cap with spermicide
• Vasectomized partner (minimum 6 months since vasectomy prior to study treatment administration)
• If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses prior to study treatment administration)
• A male study subject must agree to use one of the accepted contraceptive regimens during the entire study duration;
• Abstinence from heterosexual intercourse
• Female partner with condom with spermicide used by male study subject
• Female partner of non-childbearing potential
• Male sterilization (if proof of sterilization is not provided, the subject must agree to use one of the above accepted contraceptive methods)
• A male study subject must agree not to impregnate a female or donate sperm during the entire study duration

Exclusion Criteria

• Subject vaccinated against HAV, as documented the in medical history at the screening visit
• Subject with positive anti-HAV antibodies in blood sample at the screening visit
• Subject who previously received any type of IG, including HAV IG within the past 12 months prior to study treatment administration
• Subject with prolonged International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) at the screening visit
• Subject with a platelet count below 100×109/L at the screening visit
• Subject suffering from some acute or chronic medical, surgical or psychiatric significant condition or laboratory abnormality at the screening visit or prior to study treatment administration that, according to Investigator judgement, may increase the risk associated with study participation or study treatment administration, or may interfere with the successful completion or interpretation of the study results
• Subject with a history of the following: angioedema, cardiac arrhythmia, angina pectoris, myocardial infarction, cerebrovascular accident, cardiac failure, thrombotic events, embolism, coagulopathy, diabetes mellitus, hyperlipidaemia, nephrotic syndrome, acute renal injury, chronic obstructive pulmonary disease, asthma, hepatic disease, reticuloendothelial system dysfunction, or nervous system disorder
• Subject with known personal or family history of abnormal bleeding episodes
• Subject not willing to receive study treatment via IM route of administration or unable to receive study treatment via IM route of administration
• Subject with cardiovascular risk factors based on medical history: active tobacco smoking and/or ongoing diabetes mellitus at the screening visit
• Subject with thrombosis risk factors: prolonged immobilization within 2 months prior to the screening visit, hist