Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Inclusion Criteria:

1. Healthy men and women;
2. Age 18 to 60 years, inclusive;
3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
4. Female subjects must be of non-childbearing potential;
5. Male subjects must agree to use a double barrier method of birth control;
6. Signed informed consent form (ICF) prior to study procedures.

Exclusion Criteria:

1. Current or recent (within 14 days of Day 0) bacterial or viral infection;
2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
3. Clinically significant abnormalities noted on ECG;
4. Safety laboratory abnormalities;
5. Regular use of medications, prescription or non-prescription;
6. Poor vein access or fear of venipuncture or sight of blood;
7. Major surgery, significant recent injury or trauma within 30 days;
8. Received an investigational drug or vaccine within 30 days.