Safety Study of Immune System Modulator for Autoimmune Diseases

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243683
• Other study ID #: AX-024-1.01
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2014
• Last updated: October 13, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Artax Biopharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AX-024.HCl

Other:
• Placebo

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil	Cardiff Road

Sponsors (5)

Lead Sponsor	Collaborator
Artax Biopharma Inc	Centro de Biología Molecular Severo Ochoa, Spain (CBMSO), ORION Clinical Services, Packaging Coordinators Inc, Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious and Non-Serious Adverse Events		Over a 72 hours period and 7 days after last dose	Yes
Secondary	Area Under the Concentration-Time Curve		Over a 72 hours period post dose	No