A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP (NCT07119125)
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRT-8102 in Healthy Participants and in Participants at Cardiovascular Risk With Elevated CRP
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).
Location: Clinical Pharmacology of Miami, LLC — Miami, Florida
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Clinical Pharmacology of Miami, LLC — Miami, Florida
- ICON Clinical Research — Lenexa, Kansas
- QPS — Springfield, Missouri
- Endeavor Clinical Trials — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: 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 ...
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.