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

This is a single center, open-label, single-arm study design, in which approximately 28
subjects will receive the same study treatment (0.2 mL/kg dose via IM injection). There is no
reference therapy in this study.

The study will be explained to each subject prior to the subject providing written informed
consent. All subjects will be screened to ensure that all the inclusion criteria and none of
the exclusion criteria are met.

A sufficient number of healthy male and female subjects will be qualified by screening
assessments and procedures for reporting to the clinical site on Day -1. The healthy subjects
will receive a single IM dose of GamaSTAN (0.2 mL/kg) on Day 1. Subjects will be discharged
from the clinic on Day 2, following the scheduled assessments and procedures, and will return
to the clinical site for the remaining ambulatory PK samples and safety monitoring, and again
for the final visit (Day 150).

The total duration of study participation for subjects who complete the study will be
approximately 178 days.

Inclusion Criteria:

1. Male subjects from 18 to 55 years of age, inclusive, or female subjects from 18 to 65
years of age, inclusive

2. Subjects with a body mass index (BMI) of 18.5 to 29.9 kg/m2

3. Body weight greater than or equal to 50 kg at screening

4. Subjects willing and able to provide written informed consent

5. Subjects in good health in the judgment of the Investigator, as determined by medical
history, physical examination, vital signs, ECG and laboratory assessments

6. A female study subject must meet one of the following criteria:

1. 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)

2. 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)

7. 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)

8. A male study subject must agree not to impregnate a female or donate sperm during the
entire study duration

Exclusion Criteria:

1. Subject vaccinated against HAV, as documented the in medical history at the screening
visit

2. Subject with positive anti-HAV antibodies in blood sample at the screening visit

3. Subject who previously received any type of IG, including HAV IG within the past 12
months prior to study treatment administration

4. Subject with prolonged International Normalized Ratio (INR) or activated partial
thromboplastin time (aPTT) at the screening visit

5. Subject with a platelet count below 100×109/L at the screening visit

6. 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

7. 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

8. Subject with known personal or family history of abnormal bleeding episodes

9. Subject not willing to receive study treatment via IM route of administration or
unable to receive study treatment via IM route of administration

10. Subject with cardiovascular risk factors based on medical history: active tobacco
smoking and/or ongoing diabetes mellitus at the screening visit

11. Subject with thrombosis risk factors: prolonged immobilization within 2 months prior
to the screening visit, history of venous or arterial thrombosis, use of estrogens (30
days prior to the study drug administration), indwelling central vascular catheters
and hyperviscosity or hypercoagulable states

12. Subject with known history of hypersensitivity/allergic reaction to blood/plasma
products

13. Subject with known selective IgA deficiency (with or without antibodies to IgA)

14. Subject who received any plasma-derived product infusion within 12 months prior to
study treatment administration

15. Subject who received a blood or plasma transfusion within 12 months prior to study
treatment administration

16. Subject with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at
the screening visit and prior to treatment administration

17. Subject with anemia (hemoglobin <12 g/dL in women and 13 g/dL in men) at the screening
visit

18. Subjects with proteinuria (>1+ on urine dipstick), blood urea nitrogen (BUN) or
creatinine greater than the upper limit of normal at the screening visit

19. Subject with liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase
[ALT] and gamma-glutamyl transferase [GGT]) levels greater than the upper limit of
normal at screening visit

20. Subject who received any dose of parenteral, oral, or inhaled corticosteroids,
immunosuppressants, or immunomodulators within 6 weeks prior to the screening visit

21. Subject who received any live virus vaccine within five months prior to the screening
visit

22. Subject not willing to postpone receiving any live virus vaccines until 6 months after
receiving IP

23. Currently receiving any anti-viral treatment, regardless of the route of
administration

24. Subject with virus safety laboratory results (serology and/or nucleic acid
amplification technology [NAT]) indicative of a current infection with hepatitis A
virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency
virus (HIV) or parvovirus B19 (B19V) at the screening visit

25. Participated in another clinical trial within 30 days prior to the screening visit or
has received any IPs within 3 months prior to the screening visit

26. Positive urine drug panel testing at the screening visit or prior to study treatment
administration

27. Known or suspected abuse of alcohol, opiates, psychotropic agents or other drugs or
chemical substances; or has done so in the 12 months prior to the screening visit

28. In the opinion of the Investigator, the subject may have compliance problems with the
protocol and the procedures of the protocol

29. Subject who has already been included in a previous group for this clinical study