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Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants

Recruiting
18 - 55 years of age
Both
Phase 1

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Overview

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 at 2 different infusion durations.

Eligibility

Inclusion Criteria:

  1. Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
  2. Participant who could become pregnant must meet conditions as defined in the protocol.

Exclusion Criteria:

  1. History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
  2. Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study investigational product (IP) (mRNA-0184).
  3. Any clinically significant abnormalities in clinical laboratory results at Screening. Repeat assessments are allowed at the Investigator's discretion if a false positive is suspected.
  4. Clinically significant abnormal findings in vital signs at Screening.
  5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
  6. Use of any prescribed medication during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study IP. Hormonal contraception is permitted.
  7. Has received another IP within 4 weeks of the first dosing of the study IP or within 5 terminal half-lives of the IP, whichever is longer.

Study details

Healthy Participants

NCT06243770

ModernaTX, Inc.

30 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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