Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT07226895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis
Sponsor:
Monument Therapeutics Limited
Organization:
Study Overview
Official Title:
A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01MH137298 | NIH | None | https://reporter.nih.gov/quic… | View |
| U24MH137171 | NIH | None | https://reporter.nih.gov/quic… | View |