Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MRT-8102 · 1 trial · 2 indications
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (MRT-8102) | EXPERIMENTAL | Single Dose of MRT-8102 |
| Part 1: Single Ascending Dose (Placebo) | PLACEBO_COMPARATOR | Single Dose of Placebo |
| Part 2: Multiple Ascending Dose (MRT-8102) | EXPERIMENTAL | 7-day Daily Dose of MRT-8102 |
| Part 2: Multiple Ascending Dose (Placebo) | PLACEBO_COMPARATOR | 7-day Daily Dose of Placebo |
| Part 3: elevated CRP (MRT-8102) | EXPERIMENTAL | 28-day Daily Dose of MRT-8102 |
| Part 3: elevated CRP (Placebo) | PLACEBO_COMPARATOR | 28-day Daily Dose of Placebo |
| Name | Type | Description |
|---|---|---|
| MRT-8102 | DRUG | Oral capsules |
| Placebo | DRUG | Oral capsules |
Eligibility Criteria: Inclusion Criteria (all parts) * Healthy, adult, male or females 18-65 years of age * Non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to start of study * Able to swallow oral medications * Abstain from caffeine- and methylxan...
MRT-8102 is an investigational small molecule developed by Monte Rosa Therapeutics, Inc. It is being studied in a first-in-human Phase 1 clinical trial in healthy participants and in participants at cardiovascular risk with elevated C-reactive protein (CRP). The specific disease indications for MRT-8102 have not been disclosed.
MRT-8102 targets NEK7, a protein. NEK7 is a kinase that has been studied in the context of inflammation, including pathways related to the NLRP3 inflammasome. Monte Rosa Therapeutics is developing MRT-8102 as a small molecule directed at this protein target.
MRT-8102 is being developed by Monte Rosa Therapeutics, Inc., a biotechnology company that trades on the Nasdaq under the ticker symbol GLUE. Monte Rosa Therapeutics is the sponsor of the clinical program evaluating MRT-8102.
MRT-8102 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing study is a first-in-human trial, and no completed trials of MRT-8102 have been reported.
MRT-8102 is being evaluated in one active clinical trial, NCT07119125, titled "A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP." The Phase 1 study is active but not recruiting, is placebo-controlled and double-blind, and plans to enroll about 100 participants in the United States.
MRT-8102 is being studied in a Phase 1 trial that enrolls healthy volunteers and participants at cardiovascular risk with elevated C-reactive protein (CRP). The trial is a three-part, first-in-human study. The specific disease indications that Monte Rosa Therapeutics may pursue for MRT-8102 have not been disclosed.