Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Last updated: February 4, 2025
Sponsor: Mozart Therapeutics Australia Pty Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus Types I And Ii

Celiac Disease

Diabetes Mellitus, Type 1

Treatment

MTX-101

Placebo

Clinical Study ID

NCT06324604
MT-101-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (Day 1).

  • Healthy individuals without known current or chronic medical conditions, includingno history of any autoimmune diseases, in the opinion of the Investigator.

  • Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2.

  • Body weight ≥ 45and ≤ 100 kg.

  • Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to eachdose.

  • Persons of child-bearing potential must have a negative pregnancy test and eitherabstain from sex or use highly effective method(s) of birth control from Day 1through the duration of the study.

Exclusion

Exclusion Criteria:

  • Clinically significant findings in physical examination (PE), vital signs (bloodpressure, heart rate, and body temperature), electrocardiogram (ECG), and safetylaboratory parameters at Screening in the opinion of the Investigator.

  • Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI)equation with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 orabnormal level of proteinuria detected by dipstick at the time of Screening.

  • Any disease or condition that, in the opinion of the Investigator, mightsignificantly compromise the cardiovascular, hematological, renal, hepatic,pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous,or gastrointestinal (including an ulcer) systems.

  • Receipt of an investigational drug within 28 days or 5 half-lives (whichever islonger) of the investigational drug(s) prior to Day 1.

  • Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.

  • Positive test results for drug screen, including alcohol, at the time of Screeningor on Day 1 prior to randomization.

  • Use of tobacco or nicotine-containing products more than the equivalent of 5cigarettes/week within 30 days prior to (first) dosing.

Participants must abstain from nicotine use while inpatient.

  • History of receiving a live vaccine within 1 month of Screening.

  • History of splenectomy.

  • History of COVID or influenza vaccine within 2 weeks prior to Screening.

  • Planning to receive any vaccinations during the study period.

  • History of recurrent infections of uncertain cause.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: MTX-101
Phase: 1
Study Start date:
June 13, 2024
Estimated Completion Date:
April 30, 2026

Study Description

This is a prospective, multi-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA) and participants with celiac disease (CeD) and type 1 diabetes (T1D). This study will enroll HAs only in Part A and CeD and T1D patients only in Part B.

Connect with a study center

  • Wesley Research Institute

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Nucleus Network Brisbane

    Herston, Queensland 4006
    Australia

    Completed

  • The Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Active - Recruiting

  • Eastern Health; Box Hill Hospital

    Box Hill, Victoria
    Austria

    Active - Recruiting

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