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

Monte Rosa Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers; Elevated CRP

Treatments: Drug: Placebo; Drug: MRT-8102

Study type: Interventional

Funder types: Industry

Identifiers

NCT07119125

MRT-8102-001

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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100 participants in 6 patient groups, including a placebo group

Part 1: Single Ascending Dose (MRT-8102)

Experimental group

Description:

Single Dose of MRT-8102

Treatment:

Drug: MRT-8102

Part 1: Single Ascending Dose (Placebo)

Placebo Comparator group

Description:

Single Dose of Placebo

Treatment:

Drug: Placebo

Part 2: Multiple Ascending Dose (MRT-8102)

Experimental group

Description:

7-day Daily Dose of MRT-8102

Treatment:

Drug: MRT-8102

Part 2: Multiple Ascending Dose (Placebo)

Placebo Comparator group

Description:

7-day Daily Dose of Placebo

Treatment:

Drug: Placebo

Part 3: elevated CRP (MRT-8102)

Experimental group

Description:

28-day Daily Dose of MRT-8102

Treatment:

Drug: MRT-8102

Part 3: elevated CRP (Placebo)

Placebo Comparator group

Description:

28-day Daily Dose of Placebo

Treatment:

Drug: Placebo