Healthy Volunteers
Conditions
Keywords
MRT-6160, MRT-6160-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD, MAD
Brief 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. 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
Interventions
DRUGMRT-6160
Orally administered tablets or capsules of MRT-6160
DRUGPlacebo
Orally administered tablets or capsules of placebo
Sponsors
Monte Rosa Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Sequential Ascending Doses, Multiple Ascending Doses
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects | 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 | 7.5 weeks | Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 6 - 8 weeks | Peak plasma Concentration (Cmax) |
Countries
United States
Outcome results
None listed