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.
A Phase 1, Part A -prospective, randomized, single-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). Part B - A multi-center, randomized, open-label study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in participants with type 1 diabetes (T1D).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
96
Austin Health
Heidelberg, Victoria, Australia
RECRUITINGThe Royal Melbourne Hospital
Melbourne, Victoria, Australia
RECRUITINGSt Vincent's Hospital Melbourne (SVHM)
Fitzroy, 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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Time frame: Enrollment to 11 weeks following the last dose