Elevated CRP, Healthy Volunteers
Conditions
Keywords
MRT-8102, MRT-8102-001, MRT, Monte Rosa Therapeutics, Healthy Volunteers, Single Ascending Dose, Multiple Ascending Dose, SAD, MAD, CRP, Cardiovascular Risk
Brief 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. 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
Interventions
DRUGMRT-8102
Oral capsules
DRUGPlacebo
Oral capsules
Sponsors
Monte Rosa Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants | Up to 8 days | Peak plasma Concentration (Cmax) |
| Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants | Up to 8 days | Area under the plasma concentration versus time (AUC) |
| Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants | Up to 8 days | Peak plasma Concentration (Cmax) - comparing fasted vs fed |
| 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 | Up to 8 days | Area under the plasma concentration versus time (AUC) - comparing fasted vs fed |
| Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants | Up to 14 days | Peak plasma Concentration (Cmax) |
| Characterize the PK profile (plasma concentration versus time) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants | Up to 14 days | Area under the plasma concentration versus time (AUC) |
| Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP | Up to 35 days | Peak plasma Concentration (Cmax) |
| Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP | Up to 35 days | Area under the plasma concentration versus time (AUC) |
| Assess the impact of MRT-8102 on serum concentration of CRP | Up to 35 days | Mean changes from pre-dose baseline in serum CRP levels. |
Countries
United States
Outcome results
None listed