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

PHASE1NOT_YET_RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 ≥ 45 and ≤ 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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-01

Primary completion: 2025-12-01

Study completion finish: 2025-12-01

Study type

BASIC_SCIENCE

Phase

PHASE1

Trial ID

NCT06324604

Intervention or treatment

DRUG: Placebo

DRUG: MTX-101

Conditions

• Healthy Volunteers
• Celiac Disease
• Type 1 Diabetes

Condition: Healthy Volunteers, Celiac Disease and more
DRUG: Placebo and other drugs
Herston, Queensland, Australia
Sponsor: Mozart Therapeutics Australia Pty Ltd

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Find a site

Closest Location:

Nucleus Network Brisbane

Research sites nearby

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Nucleus Network Brisbane
Herston, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: Cohort A1S - Healthy Volunteers Cohort A1S (n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A2S - Healthy Volunteers Cohort A2S (n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A3S - Healthy Vounteers Cohort A3S (n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A4S - Healthy Volunteers Cohort A4S (n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A5Sa - Healthy Volunteers Optional Cohort A5Sa (n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A6M - Healthy Volunteers Cohort A5M (n=8): MTX-101,Dose Level 4 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A7M - Healthy Volunteers Cohort A6M (n = 6): MTX-101, Dose Level 5 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A7Ma - Healthy Volunteers Optional Cohort A6Ma (n = 6): Dose Level 6 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort B8 - Celiac Disease or Type 1 Diabetes Patients * Dose Group 1 (n = 6): MTX-101 Dose Level 4 IV Day 1, placebo IV Day 22 * Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 3 IV Day 22	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort B9 -Celiac Disease or Type 1 Diabetes Patients Dose Group 1 (n = 6): MTX-101 Dose Level 5 IV Day 1, placebo IV Day 22 Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 5 IV (or the maximum tolerated dose in Part A MAD) Day 22	DRUG: Placebo Placebo
PLACEBO_COMPARATOR: Cohort A5Sa -Healthy Volunteers Optional Cohort A5Sa (n = 6): MTX-101, up to Dose Level 6 IV or Placebo IV, Single Dose	DRUG: Placebo Placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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
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
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
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

Frequently Asked Questions

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References

Clinical Trials Gov: Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients