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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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
Find a site
Closest Location:
Nucleus Network Brisbane
Research sites nearby
Select from list below to view details:
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
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A2S - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A3S - Healthy Vounteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A4S - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A5Sa - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A6M - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A7M - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A7Ma - Healthy Volunteers
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort B8 - Celiac Disease or Type 1 Diabetes Patients
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort B9 -Celiac Disease or Type 1 Diabetes Patients
| DRUG: Placebo
|
PLACEBO_COMPARATOR: Cohort A5Sa -Healthy Volunteers
| DRUG: 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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