Safety & PK of Single Doses of MT1980

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2022

Interventions

  • Drug: MT1980
    • single dose
  • Drug: Placebo
    • single dose

Arms, Groups and Cohorts

  • Experimental: Part 1 MT1980
  • Placebo Comparator: Part 1 Placebo
  • Experimental: Part 2 MT1980 Dose Level 1
  • Experimental: Part 2 MT1980 Dose Level 2
  • Placebo Comparator: Part 2 Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Treatment-related adverse events
    • Time Frame: Day 1 to Day 11
    • 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

Secondary Measures

  • Systemic bioavailability of MT1980
    • Time Frame: 72 hours post dose
  • Level of MT1980 in CSF
    • Time Frame: up to 7 hours post dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Monument Therapeutics Limited
  • Collaborator
    • ICON plc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Principal Investigator, Principal Investigator, Icon Early Development Services
  • Overall Contact(s)
    • Head of Development, info@monumenttx.com

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