Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)

Detailed description is noted in Brief Summary.

Inclusion Criteria:

- Male or female, 18-60 years old

- Screening body mass index between 18-32 kg/m2

- Good health, no clinically significant findings in medical history, 12-lead ECG, &
vital signs;

- Clinical lab evaluations (Chem panel [fasted at least 8 hrs], CBC, HbA1c & UA in
reference range for test lab (unless deemed not clinically significant);

- Negative test for drugs of abuse at Screening & at Check-in (includes alcohol);

- Negative hepatitis, HIV & TB screens;

- Females non-pregnant, non-lactating, & either postmenopausal for at least 1 year,
surgically sterile for at least 90 days prior to Check-in, or agree to use from the
time of consent until 90 days after Study Completion an effective form of
contraception. For all females, a pregnancy test result must be negative at Screening
& Check-in.

- Males will be sterile or agree to use from Check-in until 90 days following discharge
an effective method of contraception.

- Able to comprehend & willing to sign Informed Consent Form

Exclusion Criteria:

- Females pregnant or nursing, or childbearing potential but unwilling to use
contraception.

- History of renal or hepatic impairment; stomach or intestinal surgery or resection,
malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would
alter absorption &/or excretion of orally administered drugs (appendectomy or hernia
repair allowed);

- Anemia (hemoglobin <11.5 g/dL for females; < 13 g/dL for males) or blood donation
within 8 weeks of Check-in;

- Plasma donation within 4 weeks of Check-in;

- History of alcoholism or drug addiction within 6 months to Check-in;

- Use of drugs of abuse or prescription drugs for recreational use 6 months prior to
Check-in;

- Use of any tobacco-containing or nicotine-containing products 6 months prior to
Check-in & during study;

- Participation in another drug trial 30 days of Check-in (within 8 weeks if previous
investigational drug has immunomodulary effects, other than cathepsin S inhibition);

- History or clinical manifestations of metabolic, hepatic, renal, hematological,
pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric
disorders

- History of hypersensitivity or allergies to any drug compound

- History or presence of abnormal ECG

- Laboratory abnormality deemed clinically significant;

- Use of or inability to discontinue any prescription medications/products 14 days
prior to Check-in & during study;

- Use of certain over-the-counter, non-prescription preparations are permitted up to 3
days before first dose;

- Use of alcohol-containing, grapefruit-containing, star fruit containing foods or
beverages or "energy drinks" 72 hours to Check-in & during study;

- Poor peripheral venous access;

- Receipt of blood products 6 months to Check-in

- Subjects with history of Gilbert's Syndrome;

- Strenuous activities 48 hours before receiving experimental or placebo comparator

- Illness 5 days to drug administration

- Any acute or chronic condition