Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers (TMB-108)

Inclusion Criteria:

1. At-risk adult males and females, as assessed by a medical history, physical exam, and laboratory tests
2. At least 18 years of age and no greater than 40 years on the day of screening
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
4. In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed
5. Willing to undergo HIV Testing and counseling, and receive HIV test results
6. Agrees to use a barrier form of contraception if engaging in sexual activity at any time throughout the study and the follow-up period (males and females) - two reliable forms of contraception, one barrier and one hormonal (e.g., oral contraceptive pill, injectable or implantable contraceptive combined with diaphragm, Intra Uterine Device (IUD), or condoms), must be used if volunteers engage in sexual activity that could result in pregnancy; is anatomically sterile in self or partner; all female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Events and Procedures

Exclusion Criteria:

1. Confirmed HIV-1 or HIV-2 infection
2. Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
3. Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
4. Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria
5. Confirmed diagnosis of hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies)
6. Current confirmed STD infection
7. Prior receipt of Hepatitis A vaccine by history, or anti-hepatitis A antibodies at screening
8. Pregnant, planning a pregnancy during the trial period, or lactating
9. Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of study enrollment
10. Receipt of blood transfusion or blood products 6 months prior to study drug administration
11. Participation in another clinical study of an investigational product currently or within 30 days prior to Screening, or expected participation during this study
12. History of severe allergic reactions or known allergy to any component of the study drug
13. Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3 years
14. In the opinion of the investigator, unlikely to comply with protocol