NCT07226895 A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
| NCT ID | NCT07226895 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Monument Therapeutics Limited |
| Condition | Clinical High Risk for Psychosis (CHR) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2026-03-03 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn how tests undertaken by people at high risk of developing psychosis (aged 17 to 30 years old) change when those people are given the study drug MT1988 daily for 8 weeks. This will help identify tests that could be used in later trials developing treatments for symptoms in people at high risk of developing psychosis, to measure whether those new treatments are effective. The main question this trial aims to answer is: Can any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988? Researchers will compare the results from two dose levels of MT1988 to a placebo group. Researchers do not expect to see the test results change in participants taking placebo and this will be compared to changes expected in test results in participants taking MT1988. Participants will: * take a dose of MT1988 or placebo twice per day for 8 weeks * attend clinic appointments every two weeks to undertake assessments * report any side effects they experience to the researchers
Eligibility Criteria
Inclusion Criteria: * Aged 17 to 30 years at time of consent. * Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian). * Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR). * For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements. Exclusion Criteria: * Clinically significant medical disorder or laboratory test abnormality at Day 1. * History of or current condition which may prevent participant from complying with study procedures. * Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury. * Received antipsychotic medication equivalent to a total lifetime haloperidol dose \>50 mg. * Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening. * Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing. * Unable to abstain from marijuana use on test day prior to test completion. * History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.
Contact & Investigator
Scott Woods, M.D.
PRINCIPAL INVESTIGATOR
Yale University of Medicine
Frequently Asked Questions
Who can join the NCT07226895 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, up to 30 Years, studying Clinical High Risk for Psychosis (CHR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226895 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07226895 currently recruiting?
Yes, NCT07226895 is actively recruiting participants. Contact the research team at info@monumenttx.com for enrollment information.
Where is the NCT07226895 trial being conducted?
This trial is being conducted at Irvine, United States, Los Angeles, United States, San Francisco, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT07226895 clinical trial?
NCT07226895 is sponsored by Monument Therapeutics Limited. The principal investigator is Scott Woods, M.D. at Yale University of Medicine. The trial plans to enroll 150 participants.