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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02243683

Enrollment

Registered

2014-09-18

Start date

2014-09-30

Completion date

2015-03-31

Last updated

2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGAX-024.HCl

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026