Neuroinflammatory ResponsePhase 1NCT05429840
Safety & PK of Single Doses of MT1980
A Phase 1 study testing MT1980 in people with Neuroinflammatory Response, run by Monument Therapeutics Limited at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroinflammatory Response
- What is being tested?
- MT1980
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 4 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Neuroinflammatory Response
- Being tested
- MT1980, Placebo
- Keywords
- pharmacokinetics, neuroinflammation
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1980Drug
single dose
PlaceboDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 MT1980 | Experimental | Not described Receives: Drug: MT1980 |
| Part 1 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part 2 MT1980 Dose Level 1 | Experimental | Not described Receives: Drug: MT1980 |
| Part 2 MT1980 Dose Level 2 | Experimental | Not described Receives: Drug: MT1980 |
| Part 2 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 11
Secondary outcomes (2)
Systemic bioavailability of MT1980
Measured: 72 hours post dose
Level of MT1980 in CSF
Measured: up to 7 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jun 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroinflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monument Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Icon Early Development Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429840
- Sponsor's protocol ID
- PCD101
- Other IDs
- 2022-000252-11, MUT21622-21622X
- Status last verified
- Nov 2022
- First submitted
- 16 Jun 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429840
- Acronym / sponsor ID
- PCD101
- Conditions
- Neuroinflammatory Response
- Keywords
- pharmacokinetics, neuroinflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Monument Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 MT1980 | Experimental | Drug: MT1980 |
| Part 1 Placebo | Placebo comparator | Drug: Placebo |
| Part 2 MT1980 Dose Level 1 | Experimental | Drug: MT1980 |
| Part 2 MT1980 Dose Level 2 | Experimental | Drug: MT1980 |
| Part 2 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1980single dose | Drug | Part 1 MT1980, Part 2 MT1980 Dose Level 1, Part 2 MT1980 Dose Level 2 |
| Placebosingle dose | Drug | Part 1 Placebo, Part 2 Placebo |
Primary outcome
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
2 secondary outcomes
Systemic bioavailability of MT1980
Time frame: 72 hours post dose
Level of MT1980 in CSF
Time frame: up to 7 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator principal investigator
Icon Early Development Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT1980 in people with Neuroinflammatory Response, run by Monument Therapeutics Limited at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: Day 1 to Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.