Healthy VolunteersPhase 1NCT07119125
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 testing MRT-8102 in people with Healthy Volunteers and Elevated CRP, run by Monte Rosa Therapeutics, Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Elevated CRP
- What is being tested?
- MRT-8102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jun 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Evidence of cardiovascular risk factors
- No signs or symptoms of acute disease
- No ECG finding of clinical significance
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
ICON Clinical Research
Lenexa, Kansas, 66219
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33172
Endeavor Clinical Trials
San Antonio, Texas, 78240
QPS
Springfield, Missouri, 65807
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRT-8102 in Healthy Participants and in 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 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.
Read more
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
Read the 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
- Conditions
- Healthy Volunteers, Elevated CRP
- Being tested
- MRT-8102, Placebo
- Keywords
- MRT-8102, MRT-8102-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD, MAD, CRP, Cardiovascular Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRT-8102Drug
Oral capsules
PlaceboDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (MRT-8102) | Experimental | Single Dose of MRT-8102 Receives: Drug: MRT-8102 |
| Part 1: Single Ascending Dose (Placebo) | Placebo comparator | Single Dose of Placebo Receives: Drug: Placebo |
| Part 2: Multiple Ascending Dose (MRT-8102) | Experimental | 7-day Daily Dose of MRT-8102 Receives: Drug: MRT-8102 |
| Part 2: Multiple Ascending Dose (Placebo) | Placebo comparator | 7-day Daily Dose of Placebo Receives: Drug: Placebo |
| Part 3: elevated CRP (MRT-8102) | Experimental | 28-day Daily Dose of MRT-8102 Receives: Drug: MRT-8102 |
| Part 3: elevated CRP (Placebo) | Placebo comparator | 28-day Daily Dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
To evaluate the safety and tolerability of multiple ascending 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
Measured: 21 days
To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP
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
Measured: 56 days
Secondary outcomes (9)
Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants
Peak plasma Concentration (Cmax)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start27 Jun 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monte Rosa Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119125
- Sponsor's protocol ID
- MRT-8102-001
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRT-8102 in Healthy Participants and in Participants at Cardiovascular Risk With Elevated CRP
- ClinicalTrials.gov ID
- NCT07119125
- Acronym / sponsor ID
- MRT-8102-001
- Conditions
- Healthy Volunteers, Elevated CRP
- Keywords
- MRT-8102, MRT-8102-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Monte Rosa Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (MRT-8102) | Experimental | Drug: MRT-8102Single Dose of MRT-8102 |
| Part 1: Single Ascending Dose (Placebo) | Placebo comparator | Drug: PlaceboSingle Dose of Placebo |
| Part 2: Multiple Ascending Dose (MRT-8102) | Experimental | Drug: MRT-81027-day Daily Dose of MRT-8102 |
| Part 2: Multiple Ascending Dose (Placebo) | Placebo comparator | Drug: Placebo7-day Daily Dose of Placebo |
| Part 3: elevated CRP (MRT-8102) | Experimental | Drug: MRT-810228-day Daily Dose of MRT-8102 |
| Part 3: elevated CRP (Placebo) | Placebo comparator | Drug: Placebo28-day Daily Dose of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRT-8102Oral capsules | Drug | Part 1: Single Ascending Dose (MRT-8102), Part 2: Multiple Ascending Dose (MRT-8102), Part 3: elevated CRP (MRT-8102) |
| PlaceboOral capsules | Drug | Part 1: Single Ascending Dose (Placebo), Part 2: Multiple Ascending Dose (Placebo), Part 3: elevated CRP (Placebo) |
Primary outcome
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
Time frame: 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.
Time frame: 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
Time frame: 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
9 secondary outcomes
Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants
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
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
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
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
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
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
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
Time frame: Up to 35 days
Assess the impact of MRT-8102 on serum concentration of CRP
Time frame: Up to 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRT-8102 in people with Healthy Volunteers and Elevated CRP, run by Monte Rosa Therapeutics, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.