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

Moderna

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: mRNA-0184

Study type: Interventional

Funder types: Industry

Identifiers

NCT06243770

mRNA-CRTX-001

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 6 patient groups

Cohort 1: mRNA-0184 Dose Level A

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184

Cohort 2: mRNA-0184 Dose Level B

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184

Cohort 3: mRNA-0184 Dose Level C

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184

Cohort 4: mRNA-0184 Dose Level D

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184

Cohort 5: mRNA-0184 Dose Level E

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184

Cohort 6: mRNA-0184 Dose Level F

Experimental group

Description:

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.

Treatment:

Drug: mRNA-0184