Safety Study of Immune System Modulator for Autoimmune Diseases

A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects

The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.

Inclusion Criteria:

• Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
• In good health as determined by medical history, physical examination, and clinical judgment of the investigator
• Subject with no history of autoimmune disease or cardiac disease
• Subjects must be available to complete the study (including follow-up visit).
• Subjects must satisfy a medical examiner about their fitness to participate in the study.
• Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

• A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
• Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
• Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
• Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
• A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
• A clinically significant history of drug or alcohol abuse.
• Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).