Safety Study of Immune System Modulator for Autoimmune Diseases

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AX-024.HCl
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo | Drug: AX-024.HCl<br> <br> Other: Placebo<br> <br> |
| Experimental: Cohort B<br>Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo | Drug: AX-024.HCl<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events |  | Over a 72 hours period and 7 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time Curve |  | Over a 72 hours period post dose |