Safety Study of Immune System Modulator for Autoimmune Diseases
- Registration Number
- NCT02243683
- Lead Sponsor
- Artax Biopharma Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort A AX-024.HCl Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo Cohort A Placebo Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo Cohort B AX-024.HCl Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo Cohort B Placebo Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo
- Primary Outcome Measures
Name Time Method Number of Participants with Serious and Non-Serious Adverse Events Over a 72 hours period and 7 days after last dose
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve Over a 72 hours period post dose
Trial Locations
- Locations (1)
Simbec Research Ltd
🇬🇧Merthyr Tydfil, Cardiff Road, United Kingdom