| Trial ID: | L2958 |
| Source ID: | NCT06324604
|
| Associated Drug: |
Placebo
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| Title: |
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
|
| Acronym: |
|
| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Healthy Volunteers|Celiac Disease|Type 1 Diabetes
|
| Interventions: |
DRUG: Placebo|DRUG: MTX-101
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| Outcome Measures: |
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|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|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 | 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|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
|
| Sponsor/Collaborators: |
Sponsor: Mozart Therapeutics Australia Pty Ltd
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
|
| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2024-06-13
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| Completion Date: |
2026-04
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| Results First Posted: |
|
| Last Update Posted: |
2025-02-06
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| Locations: |
Wesley Research Institute, Auchenflower, Queensland, 4066, Australia|Nucleus Network Brisbane, Herston, Queensland, 4006, Australia|The Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia|Eastern Health; Box Hill Hospital, Box Hill, Victoria, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT06324604
|
