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Clinical Trials in Australia / NCT06324604
Recruiting Phase 1

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

NCT06324604 · tracked via the Priya Life Science Australia tracker
Sponsor
Mozart Therapeutics Australia Pty Ltd
Phase
Phase 1
Started
2024-06-13
Last updated
2026-05-18

Condition(s) studied

Healthy VolunteersType 1 Diabetes

Investigational drug(s) / intervention(s)

PlaceboMTX-101

Placebo: MTX-101

MTX-101: MTX-101 (bispecific CD8 Treg modulator)

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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, including no history of any autoimmune diseases, in the opinion of the Investigator. * Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 AND body weight ≥ 55 and ≤ 120 kg. * Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose. * Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study. Exclusion Criteria: * Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator. * Prior or concurrent malignancies. * Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening. * Any disease or condition that, in the opinion of the Investigator, might significantly 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 is longer) 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 Screening or on Day 1 prior to randomization. * Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Austin Health Heidelberg Victoria Recruiting
The Royal Melbourne Hospital Melbourne Victoria Recruiting
St Vincent's Hospital Melbourne (SVHM) Fitzroy Australia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06324604 on ClinicalTrials.gov ↗ ← All trials in Australia