Healthy VolunteersPhase 1NCT06597799
First-in-human Study of MRT-6160 in Healthy Subjects
A Phase 1 study testing MRT-6160 in people with Healthy Volunteers, run by Monte Rosa Therapeutics, Inc at 2 sites in United States.
Trial summary
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRT-6160
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2024to 10 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male or females 19-65 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
- Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
- Underwent surgical intervention or an operation within 4 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
- Female subject with a positive pregnancy test or who is lactating
- Positive urine drug or alcohol screen results
- Positive COVID-19 results indicating recent or current COVID-19
- 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-lives (if known) prior to start of study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion, Inc.
Tempe, Arizona, 85283
About this study
Official title: Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.
Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
Read the detailed description
Detailed Description:
The purpose of this study is to:
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
- Conditions
- Healthy Volunteers
- Being tested
- MRT-6160, Placebo
- Keywords
- MRT-6160, MRT-6160-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD, MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRT-6160Drug
Orally administered tablets or capsules of MRT-6160
PlaceboDrug
Orally administered tablets or capsules of placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Single Ascending Dose of either:
MRT-6160 or matching placebo Receives: Drug: MRT-6160; Drug: Placebo |
| Multiple Ascending Dose | Experimental | Multiple Ascending Dose of either:
MRT-6160 or matching placebo Receives: Drug: MRT-6160; 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 ascending doses of MRT-6160 in healthy adult subjects
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
Measured: 6 weeks
To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
Measured: 7.5 weeks
Secondary outcomes (3)
To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects.
Measured: 6 - 8 weeks
To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
Peak plasma Concentration (Cmax)
Measured: 6 - 8 weeks
To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
Area under the plasma concentration versus time (AUC)
Measured: 6 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Aug 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
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
- Model description
- Sequential Ascending Doses, Multiple Ascending Doses
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monte Rosa Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CRO, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597799
- Sponsor's protocol ID
- MRT-6160-001
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06597799
- Acronym / sponsor ID
- MRT-6160-001
- Conditions
- Healthy Volunteers
- Keywords
- MRT-6160, MRT-6160-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Monte Rosa Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (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-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.
Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
Detailed description
Detailed Description:
The purpose of this study is to:
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Ascending Doses, Multiple Ascending Doses
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: MRT-6160, Drug: PlaceboSingle Ascending Dose of either: MRT-6160 or matching placebo |
| Multiple Ascending Dose | Experimental | Drug: MRT-6160, Drug: PlaceboMultiple Ascending Dose of either: MRT-6160 or matching placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, adult, male or females 19-65 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
- Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol
Key exclusion criteria (8 listed)
- History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
- Underwent surgical intervention or an operation within 4 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
- Female subject with a positive pregnancy test or who is lactating
- 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-6160Orally administered tablets or capsules of MRT-6160 | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboOrally administered tablets or capsules of placebo | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects
Time frame: 6 weeks
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects
Time frame: 7.5 weeks
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
3 secondary outcomes
To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects.
Time frame: 6 - 8 weeks
To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
Time frame: 6 - 8 weeks
To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
Time frame: 6 - 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
CRO principal investigator
Celerion
2 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-6160 in people with Healthy Volunteers, run by Monte Rosa Therapeutics, Inc at 2 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 ascending doses of MRT-6160 in healthy adult subjects (time frame: 6 weeks). The study lists 2 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 28 Jul 2025.