Actively Recruiting
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Led by Mozart Therapeutics Australia Pty Ltd · Updated on 2026-03-19
96
Participants Needed
4
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults, age 63 18 and 64 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) 63 18 kg/m2 and 64 35 kg/m2 AND body weight 63 55 and 64 120 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.
You will not qualify if you...
- Clinically significant findings in physical examination, vital signs, electrocardiogram, and safety laboratory parameters at Screening in the opinion of the Investigator.
- Prior or concurrent malignancies.
- Renal function with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 or abnormal proteinuria at Screening.
- Any disease or condition that may significantly affect cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal systems.
- Receipt of an investigational drug within 28 days or 5 half-lives before Day 1.
- Positive tests for HIV type 1 or 2, hepatitis B surface antigen, or hepatitis C.
- Positive drug or alcohol screen at Screening or Day 1 prior to randomization.
- Use of tobacco or nicotine products more than 5 cigarettes per week within 30 days before dosing; participants must abstain from nicotine 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 before Screening.
- Planning to receive any vaccinations during the study.
- History of recurrent infections of uncertain cause.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Wesley Research Institute
Auchenflower, Queensland, Australia, 4066
Active, Not Recruiting
2
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
3
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
4
St Vincent's Hospital Melbourne (SVHM)
Melbourne, Victoria, Austria
Actively Recruiting
Research Team
H
Heather Director, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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