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

Launched by MOZART THERAPEUTICS AUSTRALIA PTY LTD · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial, known as MTX-101, is exploring the safety and effects of a new drug in healthy adults and those with conditions like celiac disease and type 1 diabetes. The study aims to understand how the drug behaves in the body, how long it stays there, and how it interacts with certain immune cells. It is currently recruiting participants aged 18 to 65 who are generally healthy, meaning they don’t have any serious medical conditions or autoimmune diseases.

If you or someone you know is interested in participating, the trial has specific requirements. Eligible individuals should have a healthy body weight and pass certain health tests to ensure they can safely take the medication. Participants can expect to receive the drug and undergo regular health checks during the study to monitor any potential side effects and how the drug works in their body. It’s important to note that participants will need to follow guidelines, such as avoiding tobacco and certain vaccines during the trial. This study is a key step in understanding how MTX-101 could be used to help people with immune-related conditions in the future.

Gender

ALL

Eligibility criteria

• 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 ≤ 32 kg/m2.
• • Body weight ≥ 45and ≤ 100 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.
• • 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.