Safety & PK of Single Doses of MT1980

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

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.

Study Overview

• Status: Completed
• Conditions: Neuroinflammatory Response
• Intervention / Treatment: Drug: Placebo; Drug: MT1980

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • ICON Early Development Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 MT1980	Drug: MT1980; single dose
Placebo Comparator: Part 1 Placebo	Drug: Placebo; single dose
Experimental: Part 2 MT1980 Dose Level 1	Drug: MT1980; single dose
Experimental: Part 2 MT1980 Dose Level 2	Drug: MT1980; single dose
Placebo Comparator: Part 2 Placebo	Drug: Placebo; single dose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Monument Therapeutics Limited
• Collaborators: ICON plc
• Investigators: Principal Investigator: Principal Investigator, ICON Early Development Services

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): October 4, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pharmacokinetics; neuroinflammation
• Other Study ID Numbers: PCD101; 2022-000252-11 (EudraCT Number); MUT21622-21622X (Other Identifier: Cinical Research Organisation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes