A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
Phase 1
100
about 9 months
18–65
4 sites in FL, KS, MO +1
What this study is about
Researchers are testing a new drug called MRT-8102 to see if it's safe for people who are healthy or have heart problems. The trial will involve giving the drug or a placebo (inactive pill) in different ways over several weeks.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take MRT-8102
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP, To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants., To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
Secondary: Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants, 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, Assess the impact of MRT-8102 on serum concentration of CRP, Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants, Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP, Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants, Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP, Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants