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

PCD101

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.

2022-06-01

2022-10-04

2022-10-04

Completed

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Part 1: Open Label Part 2: Blinded', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2022-11-02