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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
96
Wesley Research Institute
Auchenflower, Queensland, Australia
ACTIVE_NOT_RECRUITINGNucleus Network Brisbane
Herston, Queensland, Australia
COMPLETEDThe Royal Melbourne Hospital
Melbourne, Victoria, Australia
RECRUITINGSafety 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
Time frame: 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
Time frame: Enrollment to 11 weeks following the last dose
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)
Time frame: 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).
Time frame: 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))
Time frame: 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.
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Eastern Health; Box Hill Hospital
Box Hill, Victoria, Austria
RECRUITINGTime frame: Enrollment to 11 weeks following the last dose