Title
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
Phase
Phase 1Lead Sponsor
Artax Biopharma IncStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Healthy VolunteersIntervention/Treatment
ax-024 ...Study Participants
18The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
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).
