Safety Study of Immune System Modulator for Autoimmune Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A

Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo

Group Type EXPERIMENTAL

AX-024.HCl

Intervention Type DRUG

Placebo

Intervention Type OTHER

Cohort B

Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo

Group Type EXPERIMENTAL

AX-024.HCl

Intervention Type DRUG

Placebo

Intervention Type OTHER

Interventions

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AX-024.HCl

Intervention Type DRUG

Placebo

Intervention Type OTHER

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes