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.
Interested in this trial?
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Interventions
DRUGPlacebo
MTX-101
DRUGMTX-101
MTX-101 (bispecific CD8 Treg modulator)
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06324604
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