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OpenTrials
Completed

NCT Number: NCT02243683

Safety Study of Immune System Modulator for Autoimmune Diseases

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Ltd

Merthyr Tydfil, Cardiff Road, CF48 4DR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AX-024.HCl

Drug

Placebo

Other

Primary outcomes

  1. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: Over a 72 hours period and 7 days after last dose

Secondary outcomes

  1. Area Under the Concentration-Time Curve

    Time frame: Over a 72 hours period post dose

Sponsors and collaborators

Lead sponsor

Artax Biopharma Inc

Industry

Collaborators

  • Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)
  • ORION Clinical Services
  • Packaging Coordinators Inc
  • Simbec Research

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 18, 2014
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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