Safety Study of Immune System Modulator for Autoimmune Diseases

Artax Biopharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Other: Placebo

Drug: AX-024.HCl

Study type

Interventional

Funder types

Other

Industry

Identifiers

AX-024-1.01

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).