A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP

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

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