Safety & PK of Single Doses of MT1980

Neuroinflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429840
• Other study ID #: PCD101
• Secondary ID: 2022-000252-11MU
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: October 4, 2022

Study information

• Verified date: November 2022
• Source: Monument Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 4, 2022
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroinflammatory Response

Intervention

Drug:
• MT1980
single dose
• Placebo
single dose

Locations

Country	Name	City	State
Netherlands	Icon Early Development Services	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Monument Therapeutics Limited	ICON plc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systemic bioavailability of MT1980		72 hours post dose
Secondary	Level of MT1980 in CSF		up to 7 hours post dose