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
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants — 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. — 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 — 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
Trial sites (4)
Facility
City
Region
Status
Clinical Pharmacology of Miami, LLC
Miami
Florida
ICON Clinical Research
Lenexa
Kansas
QPS
Springfield
Missouri
Endeavor Clinical Trials
San Antonio
Texas
More Monte Rosa Therapeutics, Inc trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.