Safety, Tolerability and Pharmacokinetics of KBP-7072

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate
the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral
single ascending dose administration and with an open label food effect panel.

Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive
active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight
subjects in each dose cohort, six subjects randomized to active drug and two subjects
randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be
collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10,
12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).

Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed
conditions. The dose tested in Part 2 will be determined based on the safety, tolerability
and PK data available from Part 1. Extensive PK samplings will be collected after dosing
(pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48,
72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).

Safety assessments will include monitoring of adverse events (AEs), vital signs (blood
pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings,
12-lead electrocardiograms (ECGs), and physical examination findings.

Inclusion Criteria:

- males and surgically sterile or postmenopausal females

- aged between 18-45 years

- body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2,

- no significant medical history

- normal renal function

- good general health

Exclusion Criteria:

- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic,
immunologic, lipid metabolism disorders, or drug hypersensitivity