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NCT07119125 · ClinicalTrials.gov registry record · Phase 1
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
A Phase 1 study of Healthy Volunteers and Elevated CRP, sponsored by Monte Rosa Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT07119125: Recruiting Phase 1 study of Healthy Volunteers and Elevated CRP, sponsored by Monte Rosa Therapeutics.
NCT07119125 is a Phase 1 study of Healthy Volunteers and Elevated CRP that is actively recruiting participants, run by Monte Rosa Therapeutics. The registered enrollment target is 100 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07119125, a Phase 1 study of Healthy Volunteers and Elevated CRP, is actively recruiting participants, sponsored by Monte Rosa Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
Study Summary
The principal aim of this study is to obtain safety and tolerability data when MRT-8102 is administered orally as single and multiple doses to healthy participants and participants at cardiovascular risk with elevated CRP. This information, together with the pharmacokinetic (PK) data, will help establish the dose and dosing regimen suitable for future studies. The study drug, MRT-8102, is experimental. This is the first study in which MRT-8102 will be given to humans. Part 1: Healthy participants will receive a single oral dose of MRT-8102 or placebo on Day 1 Part 2: Healthy participants will receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days Part 3: Participants at cardiovascular risk with elevated CRP will receive multiple oral doses of MRT-8102 or placebo for 28 consecutive days
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MRT-8102
Study Locations (4)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
Kansas
- ICON Clinical Research - Lenexa
Missouri
- QPS - Springfield
Texas
- Endeavor Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-27 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT07119125 shows while recruiting
NCT07119125 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07119125 reports a single indexed study location in Florida, Kansas, Missouri.
Frequently Asked Questions
What is clinical trial NCT07119125 about?
NCT07119125 is a clinical study titled "A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP". The principal aim of this study is to obtain safety and tolerability data when MRT-8102 is administered orally as single and multiple doses to healthy participants and participants at cardiovascular risk with elevated CRP. This information, together with the pharmacokinetic (PK) data, will help esta...
What is the current status of trial NCT07119125?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-06-27. Estimated completion is 2026-03.
What conditions does trial NCT07119125 study?
This clinical trial studies the following conditions: Healthy Volunteers, Elevated CRP.
What interventions are being tested in trial NCT07119125?
The interventions under investigation include: Placebo (DRUG), MRT-8102 (DRUG).
Who is sponsoring clinical trial NCT07119125?
This trial is sponsored by Monte Rosa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07119125 being conducted?
This trial has 4 study locations across Florida, Kansas, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07119125's enrollment target sits among peer trials
100 78th of 283 higher than 204 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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