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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324604
• Other study ID #: MT-101-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Mozart Therapeutics Australia Pty Ltd
• Contact: Heather Director, Clinical Operations
• Phone: 1-253-358-9586
• Email: hwroe[@]mozart-tx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, multi-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA) and participants with celiac disease (CeD) and type 1 diabetes (T1D). This study will enroll HAs only in Part A and CeD and T1D patients only in Part B.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Celiac Disease
• Diabetes Mellitus, Type 1
• Healthy Volunteers
• Type 1 Diabetes

Intervention

Drug:
• Placebo
Placebo
• MTX-101
MTX-101 (bispecific CD8 Treg modulator)

Locations

Country	Name	City	State
Australia	Nucleus Network Brisbane	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Mozart Therapeutics Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

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