Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2025-06-12

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: mRNA-0184 Dose Level A

Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Cohort 2: mRNA-0184 Dose Level B

Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Cohort 3: mRNA-0184 Dose Level C

Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Cohort 4: mRNA-0184 Dose Level D

Sequence 1: Participants will receive infusion condition 3 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 4 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 4 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 3 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Cohort 5: mRNA-0184 Dose Level E

Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Cohort 6: mRNA-0184 Dose Level F

Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22.

Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22.

Group Type EXPERIMENTAL

mRNA-0184

Intervention Type DRUG

Intravenous infusion

Interventions

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mRNA-0184

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes