RecruitingPhase 1NCT06324604

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


Sponsor

Mozart Therapeutics Australia Pty Ltd

Enrollment

96 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is an early-stage safety study testing a new investigational drug called MTX-101 in healthy adults. The study is designed to understand how the drug behaves in the body — how it is absorbed, how long it stays in the blood, and what effects it has — before testing it in patients with specific conditions. **You may be eligible if:** - You are between 18 and 65 years old - You are generally healthy with no known chronic medical conditions or autoimmune diseases - Your body weight and BMI are within the study range (BMI 18–35; weight 55–120 kg) - You tested negative for COVID-19 within 24 hours before each dose - You are willing to use effective contraception or abstain from sex during the study (if of childbearing potential) **You may NOT be eligible if:** - You have clinically significant abnormal findings on physical exam, vital signs, or ECG - You have a history of autoimmune disease - You are pregnant or planning to become pregnant - You have significant liver, kidney, or cardiovascular conditions - You have used certain medications within a specified time before the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

MTX-101

DRUGMTX-101

MTX-101 (bispecific CD8 Treg modulator)


Locations(4)

Wesley Research Institute

Auchenflower, Queensland, Australia

Austin Health

Heidelberg, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

St Vincent's Hospital Melbourne (SVHM)

Melbourne, Victoria, Austria

View Full Details on ClinicalTrials.gov

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NCT06324604


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