A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults

Hospitalization in the last 6 months

No medicine adjustments in the last 6 months

History of anaphylaxis from any cause

History of hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens

History of vaccination with HBV prophylactic vaccine or positive for antibody to HBV Surface and Core antigens

Known exposure to HBV within the past 6 weeks

Increased alpha fetoprotein (AFP) at screening

History of hepatitis C virus (HCV) infection or positive HCV antibody, Herpes zoster, shingles or any other chronic viral infection

Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests

Known history of HIV infection or positive HIV antibody test at screening

History of demyelinating disease such as Guillain-Barre Syndrome

History of Bell's Palsy

Immunosuppression as a result of underlying illness or treatment

History of cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma or Stage 1A cervical cancer

History of Crohn's disease or ulcerative colitis

History of autoimmune disease

History of organ transplantation

Concurrent and chronic therapy with immunosuppressive drugs including systemic corticosteroids

Receipt of investigational drugs or vaccines within 30 days or 5 half lives, whichever is longer, prior to first injection with the study drug

Receipt of immunoglobulin or other blood products within 3 months prior to enrollment

Receipt of allergy shots within the preceding 7 days or expected to receive allergy shots during the study and 7 days following completion of study

Receipt of biologics

Negative histamine response on scratch test at screening

High risk for noncompliance with the protocol

Alcohol and/or IV drug abuse within the past year

Positive urine drug test at screen visit

What this study is about