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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: AX-024.HCl

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff Road
    • Merthyr Tydfil, Cardiff Road, United Kingdom, CF48 4DR
      • Simbec Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Artax Biopharma Inc
• Collaborators: Simbec Research; ORION Clinical Services; Packaging Coordinators Inc; Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AX-024-1.01