Safety & PK of Single Doses of MT1980

Study Overview
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Brief Summary
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MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat. This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.

Official Title
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A Two-part, Single Dose, Randomized, Single Blinded, Placebo Controlled, Phase I Study to Assess the Safety and Pharmacokinetics of Oral MT1980 in Healthy Volunteers When Dosed in the Fasted State

Conditions
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Neuroinflammatory Response

Intervention / Treatment
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* Drug: MT1980
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with good physical and mental health Body Mass Index 18 to 30 kg/m2 Men & women of child-bearing potential must agree to use adequate contraception Willing & able to provide written informed consent and to communicate and participate in the study Exclusion Criteria: Clinically significant abnormal biochemistry, haematology, urinalysis results Results of screening liver function or kidney function tests outside of normal ranges Heavy daily smoking or use of nicotine containing substances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 MT1980<br> | Drug: MT1980<br>* single dose<br>|
| Placebo Comparator: Part 1 Placebo<br> | Drug: Placebo<br>* single dose<br>|
| Experimental: Part 2 MT1980 Dose Level 1<br> | Drug: MT1980<br>* single dose<br>|
| Experimental: Part 2 MT1980 Dose Level 2<br> | Drug: MT1980<br>* single dose<br>|
| Placebo Comparator: Part 2 Placebo<br> | Drug: Placebo<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events | Descriptive statistics comparing MT1980 & placebo following a single dose of study drug. Number of subjects, number of events and severity of events to be reported | Day 1 to Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic bioavailability of MT1980 |  | 72 hours post dose | 
| Level of MT1980 in CSF |  | up to 7 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, neuroinflammation