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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
The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (MRT-8102) | Experimental | Single Dose of MRT-8102 |
|
| Part 1: Single Ascending Dose (Placebo) | Placebo Comparator | Single Dose of Placebo |
|
| Part 2: Multiple Ascending Dose (MRT-8102) | Experimental | 7-day Daily Dose of MRT-8102 |
|
| Part 2: Multiple Ascending Dose (Placebo) | Placebo Comparator | 7-day Daily Dose of Placebo |
|
| Part 3: elevated CRP (MRT-8102) | Experimental | 28-day Daily Dose of MRT-8102 |
|
| Part 3: elevated CRP (Placebo) | Placebo Comparator | 28-day Daily Dose of Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRT-8102 | Drug | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants | 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 | 15 days |
| To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants. | 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 | 21 days |
| To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP | 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 | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants | Peak plasma Concentration (Cmax) | Up to 8 days |
| Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants |
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Eligibility Criteria:
Inclusion Criteria (all parts)
Parts 3: Inclusion Criteria
Exclusion Criteria (All Parts)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33172 | United States | ||
| ICON Clinical Research |
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| Placebo | Drug | Oral capsules |
|
Area under the plasma concentration versus time (AUC) |
| Up to 8 days |
| Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants | Peak plasma Concentration (Cmax) - comparing fasted vs fed | Up to 8 days |
| 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 | Area under the plasma concentration versus time (AUC) - comparing fasted vs fed | Up to 8 days |
| Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants | Peak plasma Concentration (Cmax) | Up to 14 days |
| Characterize the PK profile (plasma concentration versus time) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants | Area under the plasma concentration versus time (AUC) | Up to 14 days |
| Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP | Peak plasma Concentration (Cmax) | Up to 35 days |
| Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP | Area under the plasma concentration versus time (AUC) | Up to 35 days |
| Assess the impact of MRT-8102 on serum concentration of CRP | Mean changes from pre-dose baseline in serum CRP levels. | Up to 35 days |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| QPS | Springfield | Missouri | 65807 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |