Healthy Volunteers Clinical Trial
Official title:
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
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.
Status | Not yet recruiting |
Enrollment | 96 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. - Use of Anti-inflammatory OTC medications, e.g. acetaminophen and ibuprofen, taken within 1 week prior to and during the Screening period. - 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Nucleus Network Brisbane | Herston | Queensland |
Lead Sponsor | Collaborator |
---|---|
Mozart Therapeutics Australia Pty Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | pharmacodynamics (PD) of MTX-101 | Evaluate how MTX-101 affect the immune system by the measuring the activity, presence and amount of signaling proteins and cells that help control inflammation. | Enrollment up to 11 weeks following the last dose | |
Other | Receptor occupancy of MTX-101 | To examine the binding ability of MTX-101 to targets on the cell surface. | Enrollment up to 11 weeks following the last dose | |
Primary | Safety of single, ascending dose levels of MTX-101 | Assess the safety of single, ascending dose levels of MTX-101 by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events | Enrollment to 8 weeks post dose | |
Primary | Safety of multiple, ascending dose levels of MTX-101 | Assess the safety of multiple, ascending dose levels of MTX-101by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events | Enrollment to 11 weeks following the last dose | |
Secondary | pharmacokinetics (PK) of MTX-101 | Characterize the pharmacokinetics (PK) of MTX-101 by measuring the maximum time of occurrence for maximum plasma drug concentration (Cmax) | Enrollment to 11 weeks following the last dose | |
Secondary | pharmacokinetics (PK) of MTX-101 | Characterize the pharmacokinetics (PK) of MTX-101 by measuring the time of occurrence for maximum plasma drug concentration (Tmax). | Enrollment to 11 weeks following the last dose | |
Secondary | pharmacokinetics (PK) of MTX-101 | Characterize the pharmacokinetics (PK) of MTX-101 by measuring the maximum plasma drug concentration (Cmax), minimum plasma drug concentration (Cmin), and area under the plasma drug concentration versus time curve from time 0 to last measurable concentration (AUC(0-t)) | Enrollment to 11 weeks following the last dose | |
Secondary | anti-drug antibody (ADA) formation | Evaluate incidence of anti-drug antibody (ADA) formation by measuring the detect the presence of anti-MTX-101 antibodies in participant's blood. | Enrollment to 11 weeks following the last dose |
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