Safety Study of Immune System Modulator for Autoimmune Diseases

NCT02243683 | Completed Phase 1

• 1 other identifier: AX-024-1.01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  Over a 72 hours period and 7 days after last dose

Secondary Outcomes (1)

• Area Under the Concentration-Time Curve

  Over a 72 hours period post dose

Study Arms (2)

Cohort A

EXPERIMENTAL

Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo

Drug: AX-024.HCl; Other: Placebo

Cohort B

EXPERIMENTAL

Single ascending oral administrations of AX-024.HCl (hydrochloride) and matching placebo

Drug: AX-024.HCl; Other: Placebo

Interventions

AX-024.HCl DRUG

Cohort A; Cohort B

Placebo OTHER

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Simbec Research Ltd

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

Location

Study Officials

• Girish Sharma, MBBS

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 18, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

GB (1)