Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Trial Parameters
Brief 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 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 ≤ 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)