Healthy VolunteerPhase 1NCT06728176
Safety and PK of Multiple Doses of MT1988
A Phase 1 study testing MT1988 in people with Healthy Volunteer, run by Monument Therapeutics Limited at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is: what side effects are seen while administering MT1988 for 14 days? how much of MT1988 can be measured… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MT1988
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2024to 10 Apr 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- providing informed consent
- for females of child-bearing potential with fertile male partner - willing to comply with contraception requirements
Who cannot join
- no current or past condition which may compromise the study objectives or participant safety
- no clinically significant finding at screening, including physical examination, blood tests, medical history, concomitant medication
- history of drug abuse or dependence within the previous 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Double Blinded, Randomised, Parallel Arm, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of MT1988 in Healthy Adults
The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is:
- what side effects are seen while administering MT1988 for 14 days?
- how much of MT1988 can be measured in the blood at the beginning and end of administering MT1988 for 14 days?
Researchers will include a placebo arm (dummy drug) to compare the side effects.
Participants will:
- take MT1988 every day for 14 days
- visit the clinic once per week for assessments
- keep a diary to record information between clinic appointments.
- Conditions
- Healthy Volunteer
- Being tested
- MT1988, Placebo
- Keywords
- Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1988Drug
Active Drug
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| MT1988 Dose 1 | Experimental | MT1988 Dose Level 1 (oral, twice daily) Receives: Drug: MT1988 |
| MT1988 Dose 2 | Experimental | MT1988 Dose Level 2 (oral, twice daily) Receives: Drug: MT1988 |
| MT1988 Dose 3 | Experimental | MT1988 Dose Level 3 (oral, twice daily) Receives: Drug: MT1988 |
| MT1988 Dose 4 | Experimental | MT1988 Dose Level 4 (oral, twice daily) Receives: Drug: MT1988 |
| Placebo | Placebo comparator | Placebo (oral, twice daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Data will be analysed using descriptive statistics across four dose levels and versus placebo.
Measured: From Day 1 to end of follow up (Day 21-28)
Secondary outcomes (6)
Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax
Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics
Measured: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax
Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics
Measured: Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax
Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics
Measured: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax
Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics
Measured: Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - AUC
Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics
Measured: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC
Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics
Measured: Days 14 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start25 Nov 2024
- Primary completion8 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monument Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Principal investigator, BDD Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728176
- Sponsor's protocol ID
- SCZ103
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is not appropriate for this Phase I commercial study in healthy volunteers
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Double Blinded, Randomised, Parallel Arm, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of MT1988 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06728176
- Acronym / sponsor ID
- SCZ103
- Conditions
- Healthy Volunteer
- Keywords
- Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Monument Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 11 Dec 2024 (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.
The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is:
- what side effects are seen while administering MT1988 for 14 days?
- how much of MT1988 can be measured in the blood at the beginning and end of administering MT1988 for 14 days?
Researchers will include a placebo arm (dummy drug) to compare the side effects.
Participants will:
- take MT1988 every day for 14 days
- visit the clinic once per week for assessments
- keep a diary to record information between clinic appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MT1988 Dose 1 | Experimental | Drug: MT1988MT1988 Dose Level 1 (oral, twice daily) |
| MT1988 Dose 2 | Experimental | Drug: MT1988MT1988 Dose Level 2 (oral, twice daily) |
| MT1988 Dose 3 | Experimental | Drug: MT1988MT1988 Dose Level 3 (oral, twice daily) |
| MT1988 Dose 4 | Experimental | Drug: MT1988MT1988 Dose Level 4 (oral, twice daily) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (oral, twice daily) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers
- providing informed consent
- for females of child-bearing potential with fertile male partner - willing to comply with contraception requirements
Key exclusion criteria (3 listed)
- no current or past condition which may compromise the study objectives or participant safety
- no clinically significant finding at screening, including physical examination, blood tests, medical history, concomitant medication
- history of drug abuse or dependence within the previous 2 years
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 |
|---|---|---|
| MT1988Active Drug | Drug | MT1988 Dose 1, MT1988 Dose 2, MT1988 Dose 3, MT1988 Dose 4 |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: From Day 1 to end of follow up (Day 21-28)
Data will be analysed using descriptive statistics across four dose levels and versus placebo.
6 secondary outcomes
Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax
Time frame: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax
Time frame: Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax
Time frame: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax
Time frame: Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - AUC
Time frame: Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC
Time frame: Days 14 to 17
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 17 Apr 2025.
- Individual participant dataSharing planned: No. Sharing of IPD is not appropriate for this Phase I commercial study in healthy volunteers
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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.
Medical Director principal investigator
BDD Pharma
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 MT1988 in people with Healthy Volunteer, run by Monument Therapeutics Limited at 1 site in United Kingdom.
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 3 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 17 Apr 2025. 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 United Kingdom. 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?
Incidence of treatment-emergent adverse events (time frame: From Day 1 to end of follow up (Day 21-28)). 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 17 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.