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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05429840

Enrollment

Registered

2022-06-23

Start date

2022-06-01

Completion date

2022-10-04

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroinflammatory Response

Keywords

pharmacokinetics, neuroinflammation

Brief summary

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.

Interventions

DRUGMT1980

single dose

DRUGPlacebo

single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Part 1: Open Label Part 2: Blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment-related adverse events	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

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026