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

Phase 1Active Not RecruitingNCT07119125

Monte Rosa Therapeutics, Inc100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Healthy Volunteers Elevated CRP

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 methylxanthine-containing beverages or food Parts 3: Inclusion Criteria * Elevated CRP value ≥3.0 mg/L at the time of screening * Evidence of cardiovascular risk factors * No signs or symptoms of acute disease * No ECG finding of clinical significance Exclusion Criteria (All Parts) * History or presence of clinically significant medical or psychiatric condition or disease * Underwent surgical intervention or an operation withing 6 weeks prior to start of study * Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing * Pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 3 months after the last study drug administration. * Positive urine drug or alcohol screen results * Positive results for human immunodeficiency virus (HIV), hepatitis B or Hepatitis C virus or history of resolved hepatitis * Participation in another clinical study within 30 days or within 5 half-live (if known) prior to start of study * Currently receiving other immunomodulators * History of immunodeficiency, chronic inflammatory and chronic inflammation

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants

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

Time frame: 15 days

To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.

Time frame: 21 days

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

Time frame: 56 days

Secondary Outcomes

Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants

Peak plasma Concentration (Cmax)

Time frame: Up to 8 days

Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants

Area under the plasma concentration versus time (AUC)

Time frame: Up to 8 days

Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants

Peak plasma Concentration (Cmax) - comparing fasted vs fed

Time frame: Up to 8 days

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

Area under the plasma concentration versus time (AUC) - comparing fasted vs fed

Time frame: Up to 8 days

Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants

Peak plasma Concentration (Cmax)

Time frame: Up to 14 days

Characterize the PK profile (plasma concentration versus time) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants

Area under the plasma concentration versus time (AUC)

Time frame: Up to 14 days

Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP

Peak plasma Concentration (Cmax)

Time frame: Up to 35 days

Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP

Area under the plasma concentration versus time (AUC)

Time frame: Up to 35 days

Assess the impact of MRT-8102 on serum concentration of CRP

Mean changes from pre-dose baseline in serum CRP levels.

Time frame: Up to 35 days

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes