A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP

Not Applicable

Recruiting

• Conditions: Healthy Volunteers; Elevated CRP
• Interventions: Drug: MRT-8102; Drug: Placebo

• Registration Number: NCT07119125
• Lead Sponsor: Monte Rosa Therapeutics, Inc

Brief 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

Detailed Description

The purpose of this study is to:

* Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-8102 in healthy adult participants

* Learn about the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP

Study Timeline

• Study Start: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2026-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Single Ascending Dose (MRT-8102)	MRT-8102	Single Dose of MRT-8102
Part 1: Single Ascending Dose (Placebo)	Placebo	Single Dose of Placebo
Part 2: Multiple Ascending Dose (MRT-8102)	MRT-8102	7-day Daily Dose of MRT-8102
Part 2: Multiple Ascending Dose (Placebo)	Placebo	7-day Daily Dose of Placebo
Part 3: elevated CRP (MRT-8102)	MRT-8102	28-day Daily Dose of MRT-8102
Part 3: elevated CRP (Placebo)	Placebo	28-day Daily Dose of Placebo

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants	15 days	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
To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.	21 days	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
To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP	56 days	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

Secondary Outcome Measures

Name	Time	Method
Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants	Up to 14 days	Peak plasma Concentration (Cmax)
Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP	Up to 35 days	Area under the plasma concentration versus time (AUC)
Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants	Up to 8 days	Peak plasma Concentration (Cmax) - comparing fasted vs fed
Characterize the PK profile (plasma concentration versus time) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants	Up to 14 days	Area under the plasma concentration versus time (AUC)
Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP	Up to 35 days	Peak plasma Concentration (Cmax)
Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants	Up to 8 days	Peak plasma Concentration (Cmax)
Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants	Up to 8 days	Area under the plasma concentration versus time (AUC)
Assess the effect of a high-fat/high-calorie meal on the PK (plasma concentration versus time) of MRT-8102 02 in healthy adult participants	Up to 8 days	Area under the plasma concentration versus time (AUC) - comparing fasted vs fed
Assess the impact of MRT-8102 on serum concentration of CRP	Up to 35 days	Mean changes from pre-dose baseline in serum CRP levels.

Trial Locations

Locations (1)

ICON Clinical Research; 🇺🇸 Lenexa, Kansas, United States