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
3 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2022
CompletedNovember 2, 2022
November 1, 2022
4 months
June 16, 2022
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Systemic bioavailability of MT1980
72 hours post dose
Level of MT1980 in CSF
up to 7 hours post dose
Study Arms (5)
Part 1 MT1980
EXPERIMENTALPart 1 Placebo
PLACEBO COMPARATORPart 2 MT1980 Dose Level 1
EXPERIMENTALPart 2 MT1980 Dose Level 2
EXPERIMENTALPart 2 Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monument Therapeutics Limitedlead
- ICON plccollaborator
Study Sites (1)
Icon Early Development Services
Groningen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Principal Investigator
Icon Early Development Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Part 1: Open Label Part 2: Blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
June 23, 2022
Study Start
June 1, 2022
Primary Completion
October 4, 2022
Study Completion
October 4, 2022
Last Updated
November 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share